Z-0529-2013 Class II Terminated
FDA device recall Z-0529-2013 was initiated by DePuy Mitek, Inc., A Johnson & Johnson Co. on Nov 16, 2012 and is designated Class II. 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 The recall status is terminated (terminated Dec 21, 2012). Affected quantity: 20.
Recall details
- Product Type
- Devices
- Report Date
- Dec 26, 2012
- Initiation Date
- Nov 16, 2012
- Termination Date
- Dec 21, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20
Product description
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
Distribution pattern
Nationwide Distribution including IL and NJ
Code information
Lot Number: 3611687
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0529-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026