TORNIER PERFORM HUMERAL SYSTEM recallZ-3309-2024 · Tornier, Inc · initiated Aug 29, 2024
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
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.
FDA root cause category: Under Investigation by firm
What the company is doing
Stryker issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 08/29/2024 via email. The notice explained the issue, potential risk, and requested the following actions be taken: Identify and isolate the affected units, and respond to the notice via email. Upon receipt of the response, Stryker will arrange for the return of the device. Those consignees who further distributed the product (to other sites or customers) were directed to notify those parties. For questions or concerns, contact: [email protected].
Recall details
- Recall number
- Z-3309-2024
- Status
- Open, Classified
- Initiated by the company
- Aug 29, 2024
- Posted by the FDA
- Sep 27, 2024
- Recalling firm
- Tornier, Inc
- Quantity
- 38 units
- Product code
- PAO
- FDA submissions
- K201315
- Distribution
- US Nationwide distribution.
Product description
Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Code information (models, lots, serial numbers)
GTIN 00846832084494, Batch Lot # 1495AY
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TORNIER PERFORM™ HUMERAL SYSTEM DWP2393Tornier, Inc. · shoulder prosthesis, reverse configuration1 recall2 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.
How recalls are matched to devices · Editorial policy · Report an error on this page