Tornier Perform Reversed Augmented Glenoid recallZ-0113-2024 · Tornier, Inc · initiated Sep 15, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Tornier, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process change control
What the company is doing
Stryker issued an URGENT MEDICAL DEVICE RECALL NOTICE to its consignees on 09/15/2023 by email and letter. The letter explained the issue and the risk. Actions requests were: Check inventory, quarantine, and respond to the notice. Distributors were directed to notify all applicable parties. Stryker is requesting the return of the affected product.
Recall details
- Recall number
- Z-0113-2024
- Status
- Open, Classified
- Initiated by the company
- Sep 15, 2023
- Posted by the FDA
- Oct 13, 2023
- Recalling firm
- Tornier, Inc
- Quantity
- 30 units
- Product code
- PHX
- FDA submissions
- K161742
- Distribution
- US: CA, CO, IL, MA, MN, NC, OR, RI, SC, TN
Product description
stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
Code information (models, lots, serial numbers)
UDI/DI 10846832062017, Lot Number 1756123
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Tornier Perform® Reversed Augmented Glenoid DWJ502Tornier, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall32 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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