Recall Z-0529-2013 ยท HTO Reamer
DePuy Mitek, Inc., a Johnson & Johnson Co.
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.
| Date | Dec 17, 2012 (initiated Nov 16, 2012) |
| 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 |
| Root cause | Packaging process control |
| Action | DePuy Mitek sent an Urgent Voluntary Product Recall letter dated November 16, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to refer to the attached instructions to report their inventory status and for returning the affected product. Customers with questions should call 1-508-880-8477. For questions regarding this recall call 508-880-8100. |
| Quantity | 20 |
| Distribution | Nationwide Distribution including IL and NJ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.