Class II — DePuy Mitek, Inc., a Johnson & Johnson Co.
| Recalling firm | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
|---|---|
| Registered facility | DePuy Mitek, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 |
| 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. |
| Quantity | 20 |
| Distribution | Nationwide Distribution including IL and NJ |
| Initiated | 2012-11-16 |
| Classified | 2012-12-17 |
| Terminated | 2012-12-21 |
| Recall number | Z-0529-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — DePuy Mitek, Inc., a Johnson & Johnson Co. (Z-0529-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63732/
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