FDA recall Z-2661-2017
Medacta Usa Inc · Class II · device
Product
Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
Reason for recall
One lot of product does not include a screw for attachment to the tibial base plate.
Distribution
CA, AZ, NC, Israel, France
Key facts
- Status
- Terminated
- Initiation date
- 2017-05-19
- Report date
- 2017-07-12
- Termination date
- 2018-05-29
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Memphis, TN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2661-2017