DePuy Mitek 11 MM Fully Fluted Reamer — Class II medical device recall Z-0529-2013
Terminated recall by DePuy Mitek, Inc., a Johnson & Johnson Co., reported 2012-12-26, distributed nationwide. Specific units of the DePuy Mitek Sterile Reamers are not labeled correctly, 7 units were labeled as 11MM whil
| Recall number | Z-0529-2013 |
|---|---|
| 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 | 2012-11-16 |
| Classified | 2012-12-17 |
| Reported by FDA | 2012-12-26 |
| Terminated | 2012-12-21 |
| Distributed | Nationwide (US) |
| Quantity | 20 |
| Reason classes | labeling, sterility |
| Lot numbers | 3611687 |
Product
DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut through cortical and cancellous bone during Cruciate Ligament Repair/Reconstruction of the knee.
Reason for recall
Specific units of the DePuy Mitek Sterile Reamers are not labeled correctly, 7 units were labeled as 11MM while the box actually contained a 10 MM reamer
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-0529-2013. 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.