smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
This recall has been terminated (originally issued May 4, 2018).
- Company
- Smith & Nephew Inc
- Recall Initiated
- May 4, 2018
- Terminated
- February 22, 2019
- Recall Number
- Z-2163-2018
- Quantity
- 5 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
Reason for Recall
One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.
Distribution
International only: United Arab Emirates, Spain, Mexico
Lot / Code Info
15FM16181
Root Cause
Error in labeling
Action Taken
The firm initiated the recall by email on 05/04/2018. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew. All consignees are asked to complete the Response Form, even if they do not have product to return.
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