Novation Ceramic AHS Cluster-Hole Shell recall
Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54; For use in primary total hip…
Why was Novation Ceramic AHS Cluster-Hole Shell recalled?
Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code: MRA; Catalog Number 140-01-54, Serial Numbers: 4296076, 4296078, 4296079, Exp. 2/23/2021
- 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…
- Recalling firm
- Exactech, Inc.
- Quantity
- 3 devices
- Distribution
- Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.
- Recall date
- June 8, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)