5 — Class II medical device recall Z-1574-2016
Terminated recall by Synthes (USA) Products LLC, reported 2016-05-04, distributed in IL, IN. This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped after the expirat
| Recall number | Z-1574-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2016-04-04 |
| Classified | 2016-04-27 |
| Reported by FDA | 2016-05-04 |
| Terminated | 2016-09-02 |
| Distributed | IL, IN |
| Quantity | 15 units |
| Reason classes | labeling, sterility |
| Lot numbers | 5539094 |
| Model numbers | 02.221.462S |
| Expiration dates | 2012-05-31 |
Product
5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones.
Reason for recall
This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped after the expiration date of May 31, 2012. The label on the product has the correct expiration date.
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-1574-2016. 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.