6 — Class II medical device recall Z-0139-2013
Terminated recall by Encore Medical, Lp, reported 2012-10-31, distributed nationwide. A product complaint was received where a size 20 screw was labeled as size 30. After receipt, measurement of t
| Recall number | Z-0139-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, Lp, Austin, TX, United States |
| Recall initiated | 2012-09-28 |
| Classified | 2012-10-25 |
| Reported by FDA | 2012-10-31 |
| Terminated | 2013-01-25 |
| Distributed | Nationwide (US) |
| Quantity | 1 units |
| Reason classes | labeling |
| Lot numbers | 006A1057 |
| Model numbers | 10-55-025 |
Product
6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
Reason for recall
A product complaint was received where a size 20 screw was labeled as size 30. After receipt, measurement of the screw determined it to be a size 25. Further investigation also determined that there were other screws labeled as size 25, but a size 30 screw was inside of the package. It was thought that all of these screws were found in-house and were contained, but it was determined later that on
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-0139-2013. 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.