djo surgical Screw 6 — Class II medical device recall Z-2146-2012
Terminated recall by Encore Medical, Lp, reported 2012-08-15, distributed nationwide. One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a
| Recall number | Z-2146-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, Lp, Austin, TX, United States |
| Recall initiated | 2012-07-16 |
| Classified | 2012-08-06 |
| Reported by FDA | 2012-08-15 |
| Terminated | 2012-12-04 |
| Distributed | Nationwide (US) |
| Quantity | 18 devices |
| Reason classes | labeling |
| Lot numbers | 007A1037 |
| Model numbers | 010-55-25 |
Product
djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair
Reason for recall
One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw dimension is actually 25mm.
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-2146-2012. 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.