Device product
Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11, Femoral Stem; Catalog Number 160-30-11; For use in primary total hip arthroplasty.
Z-1905-2016
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 73200
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 devices.
- Official record key
device-enforcement:Z-1905-2016
Official wording
Reason: Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
Code information: Product Codes: LPH, MEH, LWJ, JDI; Catalog Number 160-30-11, Serial Numbers: 4273184, 4273185, 4273187, 4273188, 4273189, 4273190, 4273191, 4273192 and 4273186, Exp. 2/8/2021.
Distribution pattern: Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.
Derived failure modes
-
Unknown
Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.