Norderstedt, N/A, Germany
Waldemar Link GmbH & Co. KG (Mfg Site) recalls
22 recalls recorded since 2018, most recently on 6 July 2026. 20 are listed as ongoing. Status and classification are as published by the FDA.
Recalls22
Ongoing (FDA)20
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 6 July 2026
- Reason
- The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.
- Distribution
- Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2934-2026
- Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
Ongoing Class II Medical devices
- Recall started
- 11 February 2026
- Reason
- The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
- Distribution
- US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1651-2026, Z-1652-2026
- Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
- Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
Ongoing Class II Medical devices
- Recall started
- 12 January 2026
- Reason
- The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Distribution
- Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1521-2026, Z-1517-2026, Z-1511-2026, Z-1520-2026, Z-1512-2026, Z-1515-2026, Z-1514-2026, Z-1516-2026, Z-1513-2026, Z-1518-2026, Z-1519-2026, Z-1522-2026 and 1 more
- Endo-Model Replacement Plateau; Item Number: 15-0027/11;
- Endo-Model Replacement Plateau; Item Number: 15-8030/12;
- Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
- Endo-Model Replacement Plateau; Item Number: 15-8521/15;
- Endo-Model Replacement Plateau; Item Number: 15-0027/15;
- Endo-Model Replacement Plateau; Item Number: 15-2835/12;
- Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
- Endo-Model Replacement Plateau; Item Number: 15-2836/11;
- and 5 more product lines
Ongoing Class II Medical devices
- Recall started
- 10 November 2025
- Reason
- The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
- Distribution
- US distribution to states of: AL, GA, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0890-2026
- Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.
Ongoing Class II Medical devices
- Recall started
- 31 July 2025
- Reason
- Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
- Distribution
- Worldwide - US Nationwide distribution in the states of CO, IN, NJ, TX and the countries of Germany and Italy.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2541-2025
- LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
Ongoing Class II Medical devices
- Recall started
- 15 July 2025
- Reason
- Inconsistent size terminology and color coding used on labeling
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IN, KS, LA, NJ and the countries of Germany, Argentina, Belgium, Switzerland, Cyprus, Algeria, Finland, Hungary, Mexico, Netherlands, Peru, Slovenia, and Uruguay.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2288-2025, Z-2289-2025
- Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
- Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
Ongoing Class II Medical devices
- Recall started
- 3 April 2025
- Reason
- The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IN, IL, KS, LA, MD, MO, NV, OH, TX, VA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1700-2025, Z-1702-2025, Z-1699-2025, Z-1701-2025
- Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2 - cemented lg), (5) 880-313/11 (Sz. 3-4
- Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880-331/22 (Sz. 1-2 - ce
- Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 - cemented lg), (5) 880-303/11 (Sz. 3-4 -
- L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) 880-321/12 (Sz. 1-2 - cemented sm), (4) 880-321/22 (Sz. 1-2 - cemented lg), (5) 880-323/13 (Sz. 3-4
Ongoing Class II Medical devices
- Recall started
- 14 February 2025
- Reason
- A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IN, KS, MO, NJ, NV, OH TX, VA, WI and the countries of Germany, Italy, Spain, Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1372-2025, Z-1374-2025, Z-1373-2025
- Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
- Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
- Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12
Ongoing Class II Medical devices
- Recall started
- 5 December 2024
- Reason
- Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).
- Distribution
- US Nationwide distribution in the states of AL, FL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0769-2025
- LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 Intended for revision hip arthroplas
Ongoing Class II Medical devices
- Recall started
- 22 May 2024
- Reason
- Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
- Distribution
- Nationwide Foreign: Algeria Argentina Australia Austria Belarus Belgium Brazil Bulgaria Canada China Colombia Czechia Denmark Ecuador Estonia Finland France Germany Greece Hungary India Indonesia Israel Italy Kenya Lithuania Luxembourg Mexico Netherlands Norway Peru Poland Romania Saudi Arabia Slov
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2411-2024, Z-2410-2024
- Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75mm 16-2817/32 Tibial Component Modula
- Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12
Ongoing Class II Medical devices
- Recall started
- 6 February 2024
- Reason
- Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, NJ, NV, PA, TN, TX, VA, WA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1299-2024, Z-1298-2024, Z-1296-2024, Z-1297-2024
- SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
- SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented
- SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented
- SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented
Ongoing Class II Medical devices
- Recall started
- 29 January 2024
- Reason
- The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.
- Distribution
- US Nationwide distribution in the states of AL and LA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1257-2024, Z-1258-2024
- Embrace Drill Tower, Wedged (25mm)
- Embrace Drill Tower, Standard/Lateral (25mm)
Ongoing Class II Medical devices
- Recall started
- 22 January 2024
- Reason
- Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery
- Distribution
- Worldwide - US Nationwide distribution in the states of IL, IN, FL, WA and the countries of Germany, Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1219-2024
- LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 184-280/12
Ongoing Class II Medical devices
- Recall started
- 30 November 2023
- Reason
- Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resected and not fit correctly leading to extended surgery time
- Distribution
- US Nationwide distribution in the state of NH.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0749-2024
- Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05
Ongoing Class II Medical devices
- Recall started
- 26 July 2023
- Reason
- A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp is further impacted or extracted. The rasp remains intact. The rasp would need to be pulled out by a clamp leading to a prolongation of surgery or modified surgery
- Distribution
- IN,GA, TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2481-2023
- Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty surgical procedure Item Number: 17-5220/01
Ongoing Class II Medical devices
- Recall started
- 14 July 2023
- Reason
- Product is labeled with incorrect offset.
- Distribution
- Domestic distribution to AL, NJ, NV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2641-2023
- MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination
Ongoing Class II Medical devices
- Recall started
- 3 July 2023
- Reason
- Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2348-2023, Z-2356-2023, Z-2345-2023, Z-2353-2023, Z-2346-2023, Z-2347-2023, Z-2350-2023, Z-2352-2023, Z-2349-2023, Z-2355-2023, Z-2351-2023, Z-2354-2023
- LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-117/00
- LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-25/00
- LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-114/00
- LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-22/00
- LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-115/00
- LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-116/00
- LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-119/00
- LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-121/00
- and 4 more product lines
Ongoing Class II Medical devices
- Recall started
- 23 December 2022
- Reason
- Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
- Distribution
- US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2067-2023, Z-2066-2023
- LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/21
- LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/11
Ongoing Class II Medical devices
- Recall started
- 24 May 2022
- Reason
- There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
- Distribution
- Domestic distribution to AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN, TX, WA. Foreign distribution to Algeria Argentina Australia Austria Belgium Bulgaria Canada China Colombia Denmark Ecuador Estonia Finland France Germany Great Britain Greece Hungary India Indonesia Isr
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1380-2022, Z-1377-2022, Z-1378-2022, Z-1379-2022
- Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37
- Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.
- Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11, Small, Right 15-3816/11, Small, Left 15-3816/12, Medium, Right 15-3817/11, Medi
- Tibial Component. orthopedic prosthesis. Model Nos: Small, W 16-2817/02 Medium, W 16-2817/05 Large, W 16-2817/07
Ongoing Class II Medical devices
- Recall started
- 18 March 2021
- Reason
- The firm discovered through customer complaints that device segments may not meet specifications.
- Distribution
- Domestic: AL, GA, IL, IN, KS, NJ, NY, and TX. Foreign: Argentina, Australia, Austria, Brazil, Finland, France, Germany, India, Italy, Spain, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2047-2023, Z-2049-2023, Z-2046-2023, Z-2048-2023
- LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left
- LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left
- LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right
- LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right
Terminated Class II Medical devices
- Recall started
- 7 December 2018
- Terminated
- 17 December 2019
- Reason
- The reaming guide and the guide rod can't be screwed into the intended depth. The reason for this is a reduced depth of the core hole in the stem. A reaming guide that is not screwed in completely may lead to a proximal preparation in the depth that is not sufficient and to a neck that can't be positioned correctly. The correct fit of the neck can't be verified by means of the guide rod.
- Distribution
- US Nationwide in the states of: FL, GA, IA, IN, KS, MI, MN, and TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0733-2019
- LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Product Usage: The LINK¿ STEM with Microporous Surface MP¿ Reconstruction Prosth
Terminated Class II Medical devices
- Recall started
- 4 December 2018
- Terminated
- 5 June 2020
- Reason
- The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.
- Distribution
- US distribution to states of: AZ, FL, GA, LA, MI, MN, TX, and WA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0729-2019, Z-0728-2019
- BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by con
- BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by con
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.