Warsaw, IN, United States
Nextremity Solutions recalls
7 recalls recorded since 2018, most recently on 10 February 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)0
Terminated or completed7
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 10 February 2022
- Terminated
- 10 October 2024
- Reason
- Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
- Distribution
- Distribution US Nationwide, Japan, and the Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0913-2022, Z-0914-2022, Z-0912-2022, Z-0910-2022, Z-0911-2022
- Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument
- Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument
- Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument
- Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument
- Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument
Terminated Class II Medical devices
- Recall started
- 13 January 2022
- Terminated
- 24 May 2024
- Reason
- During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ removal of the implant, use of alternative surgical approach, disassembly of the implants post-operatively, and revision
- Distribution
- US Nationwide distribution in the states of AZ, IL, GA, LA, MD, NY, PA, TX, WA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0739-2022, Z-0740-2022
- Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU: CH-MINI-KT
- Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT
Terminated Class II Medical devices
- Recall started
- 26 March 2021
- Terminated
- 10 November 2021
- Reason
- Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended
- Distribution
- AL, AK, CA, IA,IL, IN, KY ,MD. MI, NJ, NY, OR, PA, SC, TX, VA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1500-2021, Z-1501-2021
- InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
- InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
Terminated Class II Medical devices
- Recall started
- 12 February 2020
- Terminated
- 17 December 2020
- Reason
- Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the proximal Nextra implant
- Distribution
- International distribution in the countries of Spain, United Kingdom, Germany, and Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1458-2020
- Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments which is indicated f
Terminated Class II Medical devices
- Recall started
- 16 December 2019
- Terminated
- 8 September 2020
- Reason
- The product contains a different plate than indicated by the package labeling. The product is labeled as a right plate but contains a left plate.
- Distribution
- Domestic distribution to AL, CA, FL, GA, ID, IL, IA, KY, LA, ME, MA, MI, MN, MS, NE, NJ, NY, OH ,OK, OR, TX, and WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1127-2020
- Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation.
Terminated Class II Medical devices
- Recall started
- 11 November 2019
- Terminated
- 10 September 2020
- Reason
- Components 2mm shorter than indicated on the package label
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0778-2020, Z-0776-2020, Z-0777-2020
- Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST
- Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST
- Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST
Terminated Class II Medical devices
- Recall started
- 9 October 2019
- Terminated
- 24 June 2020
- Reason
- Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0534-2020
- Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotom
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.