Bloomington, MN, United States
Tornier, Inc recalls
13 recalls recorded since 2018, most recently on 5 March 2026. 9 are listed as ongoing. Status and classification are as published by the FDA.
Recalls13
Ongoing (FDA)9
Terminated or completed4
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 5 March 2026
- Reason
- Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.
- Distribution
- US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, MA, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1769-2026
- Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252
Ongoing Class II Medical devices
- Recall started
- 19 December 2025
- Reason
- A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1237-2026
- TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Ongoing Class II Medical devices
- Recall started
- 3 March 2025
- Reason
- A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct)
- Distribution
- OUS (International) Distribution to countries: Sweden, Australia, United Kingdom, Colombia, Germany
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1651-2025
- stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented
Ongoing Class II Medical devices
- Recall started
- 29 August 2024
- Reason
- One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
- Distribution
- US Nationwide distribution in the states of IL, WI, AZ, NV, SD.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3155-2024
- stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
Ongoing Class II Medical devices
- Recall started
- 29 August 2024
- Reason
- Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3309-2024
- Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Ongoing Class II Medical devices
- Recall started
- 3 January 2024
- Reason
- The incorrect device is contained in the labeled package.
- Distribution
- Distribution was made to AR, AZ, CA, CO, CT, NC, OH, TN, and VA. There was no military/government distribution. Foreign distribution was made to Australia, France, and Italy.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0773-2024
- Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.
Ongoing Class II Medical devices
- Recall started
- 15 September 2023
- Reason
- One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into the baseplate.
- Distribution
- US: CA, CO, IL, MA, MN, NC, OR, RI, SC, TN
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0113-2024
- stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
Ongoing Class II Medical devices
- Recall started
- 12 June 2023
- Reason
- A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Spain, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2020-2023, Z-2019-2023
- AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
- AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
Ongoing Class II Medical devices
- Recall started
- 3 May 2022
- Reason
- The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1216-2022
- Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
Terminated Class II Medical devices
- Recall started
- 28 May 2021
- Terminated
- 14 April 2023
- Reason
- Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.
- Distribution
- IL and TX Belgium, France and United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2025-2021
- Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
Terminated Class II Medical devices
- Recall started
- 18 October 2019
- Terminated
- 9 April 2021
- Reason
- During shipping, it is possible for the Aequalis Ascend Flex humeral stem to become unseated or otherwise move within its internal packaging restraints. Movement within the packaging may cause the product to rub against the PETG blister shipping container causing the transfer of PETG material from the blister container to the stem.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0405-2020
- Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 DWF601B 3700386944482 DWF601C 3700386944499 DWF602A 3700386944505 DWF602B 3700386944512 DWF602C 3700386944529 DWF603A 3700386944536 DWF603
Terminated Class II Medical devices
- Recall started
- 26 March 2018
- Terminated
- 12 August 2021
- Reason
- Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1757-2018
- AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Ty
Terminated Class II Medical devices
- Recall started
- 8 February 2018
- Terminated
- 7 August 2020
- Reason
- Data has shown that degradation of a raw material used in Phantom Fiber may occur more quickly than expected if improperly stored. This may impact the shelf-life of the product which could cause the suture to lose strength more quickly than expected.
- Distribution
- US Nationwide Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1374-2018
- Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB000525 5.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP000425 4.5 MM PHAN
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.