Stryker — Class II medical device recall Z-1147-2020
Terminated recall by Stryker Corporation, reported 2020-02-19, distributed in AK, AR, AZ, CA, CO, FL, GA, ID…. Complaints have been received regarding difficulty in removing the driver from the screw. High driver removal
| Recall number | Z-1147-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Corporation, San Jose, CA, United States |
| Recall initiated | 2019-07-19 |
| Classified | 2020-02-11 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2024-02-02 |
| Distributed | AK, AR, AZ, CA, CO, FL, GA, ID, IL, KY, MD, ME, NJ, NV, NY, OH, TX, UT, WI |
| Quantity | 73 devices |
| UPC / GTIN / UDI-DI | 07613327464832 |
| Model numbers | 3910-500-472 |
Product
Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197
Reason for recall
Complaints have been received regarding difficulty in removing the driver from the screw. High driver removal forces can lead to the screw pulling out still attached to the driver. This could result in an additional anchor insertion site in the bone being used.
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-1147-2020. 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.