stryker TORNIER PERFORM HUMERAL SYSTEM — Class II medical device recall Z-3155-2024
Ongoing recall by Tornier, Inc, reported 2024-09-25, distributed nationwide. One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device
| Recall number | Z-3155-2024 |
|---|---|
| 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 | 2024-09-16 |
| Reported by FDA | 2024-09-25 |
| Distributed | Nationwide (US) |
| Quantity | 5 units |
| Reason classes | microbial contamination, sterility |
| UPC / GTIN / UDI-DI | 00846832092192 |
| Lot numbers | 3268BA |
| Model numbers | DWM003A |
Product
stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
Reason for recall
One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
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-3155-2024. 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.