Screw — Class II medical device recall Z-0147-2013
Terminated recall by DePuy Mitek, Inc., a Johnson & Johnson Co., reported 2012-10-31, distributed nationwide. Fracture of SPIRALOK Anchors post op, requiring patient revision
| Recall number | Z-0147-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Mitek, Inc., a Johnson & Johnson Co., Raynham, MA, United States |
| Recall initiated | 2012-09-06 |
| Classified | 2012-10-25 |
| Reported by FDA | 2012-10-31 |
| Terminated | 2015-06-03 |
| Distributed | Nationwide (US) |
| Quantity | 66 units |
| Reason classes | device malfunction |
Product
Screw, fixation, boneProduct Number: 222967 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Reason for recall
Fracture of SPIRALOK Anchors post op, requiring patient revision
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-0147-2013. 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.