Device product
Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
Z-0201-2016
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 72357
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8
- Official record key
device-enforcement:Z-0201-2016
Official wording
Reason: Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.
Code information: Catalog Number 164-13-09 Serial Numbers: 4076815, 4076816, 4076817, 4076818, 4076819, 4076820, 4076821, and 4076822.
Distribution pattern: US Distribution to states of: AZ, CO, FL, and MD.
Derived failure modes
-
Unknown
Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.