STRYKER WEDGE INTERFERENCE SCREW SYSTEM — Class II medical device recall Z-0837-2018
Terminated recall by Stryker Corporation, reported 2018-03-14. Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
| Recall number | Z-0837-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Corporation, San Jose, CA, United States |
| Recall initiated | 2017-11-17 |
| Classified | 2018-03-02 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2024-01-29 |
| Countries outside the US | AU, MX |
| Quantity | 60,753 units |
| UPC / GTIN / UDI-DI | 04546540754561 |
| Lot numbers | 17278AG2 |
| Model numbers | 0234010056 |
Product
STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.
Reason for recall
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
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-0837-2018. 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.