Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total hip arthroplasty.
Reported: June 8, 2016 Initiated: April 12, 2016 #Z-1901-2016
Product Description
Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total hip arthroplasty.
Reason for Recall
Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
Details
- Recalling Firm
- Exactech, Inc.
- Units Affected
- 2 devices.
- Distribution
- Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.
- Location
- Gainesville, FL
Frequently Asked Questions
What product was recalled? ▼
Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total hip arthroplasty.. Recalled by Exactech, Inc.. Units affected: 2 devices..
Why was this product recalled? ▼
Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 8, 2016. Severity: Moderate. Recall number: Z-1901-2016.
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