Device product
Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54; For use in primary total hip arthroplasty.
Z-1900-2016
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 73200
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 devices
- Official record key
device-enforcement:Z-1900-2016
Official wording
Reason: Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
Code information: Product Code: MRA; Catalog Number 140-01-54, Serial Numbers: 4296076, 4296078, 4296079, Exp. 2/23/2021
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.