Stryker Tornier Perform Humeral System — Class II medical device recall Z-3309-2024
Ongoing recall by Tornier, Inc, reported 2024-10-09, distributed nationwide. Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down wh
| Recall number | Z-3309-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tornier, Inc, Bloomington, MN, United States |
| Recall initiated | 2024-08-29 |
| Classified | 2024-09-27 |
| Reported by FDA | 2024-10-09 |
| Distributed | Nationwide (US) |
| Quantity | 38 units |
| UPC / GTIN / UDI-DI | 00846832084494 |
| Lot numbers | 1495AY |
| Model numbers | DWP2393 |
Product
Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3309-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.