FDA recall Z-2163-2018
Smith & Nephew, Inc. · Class II · device
Product
smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
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
Key facts
- Status
- Terminated
- Initiation date
- 2018-05-04
- Report date
- 2018-06-20
- Termination date
- 2019-02-22
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Memphis, TN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2163-2018