FDA Device recall Z-1900-2016
Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54
- FDA Device
- Class II
- terminated
- Published 2016-06-08
On 2016-06-08 the FDA classified a Class II recall of Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54 by Exactech, citing devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1900-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-12 |
| Published | 2016-06-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Exactech |
| Distribution | FL, HI, NJ, NY, OH, OK, RI, TN, VA |
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.
Reason
Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
Identifiers
| code_info | Product Code: MRA; Catalog Number 140-01-54, Serial Numbers: 4296076, 4296078, 4296079, Exp. 2/23/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1900-2016%22
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