ACL DISPOSABLE PACK BONE-TENDON-BONE — Class II medical device recall Z-0838-2018
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. It
| Recall number | Z-0838-2018 |
|---|---|
| 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 | 07613154643264 |
| Lot numbers | 17299AG2 |
| Model numbers | 0234020280 |
Product
ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
Reason for recall
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. It is indicated to be a single surgery use, disposable set of instrumentation for anterior cruciate ligament (ACL) reconstruction surgeries.
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-0838-2018. 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.