Device product
GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic
Z-0130-2014
Product summary
- Event
- Event 66545
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-0130-2014
Official wording
Reason: Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.
Code information: Batch No. 13GM11272
Distribution pattern: USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN.
Derived failure modes
-
Unknown
Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.