Device product
Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stem, Catalog Number 160-00-13; For use in primary total hip arthroplasty.
Z-1902-2016
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 73200
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 devices.
- Official record key
device-enforcement:Z-1902-2016
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 160-00-13, Serial Numbers: 4333544, 4333545, 4333546, Exp.3/22/2021 and Serial Number 4335281, Exp. 3/23/2021.
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.