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.
This recall has been terminated (originally issued December 17, 2012).
- Recall Initiated
- November 16, 2012
- Posted
- December 17, 2012
- Terminated
- December 21, 2012
- Recall Number
- Z-0529-2013
- Quantity
- 20
- Firm Location
- Raynham, MA
- Official Source
- View on FDA website ↗
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
Distribution
Nationwide Distribution including IL and NJ
Lot / Code Info
Lot Number: 3611687
Root Cause
Packaging process control
Action Taken
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.