—#146149

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.

FDA product code: MRA — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P050039
Affected lot / code info: Product Code: MRA; Catalog Number 140-01-54, Serial Numbers: 4296076, 4296078, 4296079, Exp. 2/23/2021

Why it was recalled

Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

Root cause (FDA determination)

Packaging process control

Action the firm took

Customers were notified 4/12/2016 with a Product Recall Advisory Notice of affected products.In order to comply with applicable regulations and Exactech policies: " Immediately cease distribution or use of these products. " Extend this information to your accounts that may have this product in their possession. " Identify and quarantine any of the subject devices in your inventory " Complete and Return the attached Recall Inventory Response Form to Exactech, per the instructions provided on the notice itself. According to policy, please contact your Exactech inventory representative within 5 business days to confirm quantities at your location. If you have any inventory restocking questions related to this issue, please contact Kaya Davis at kaya@exac.com or 1-800-392-2832. Please return the products to the following address: Exactech Distribution Center 2411 NW 66th Court Gainesville, Florida 32653 Attention: Kaya Davis kaya@exac.com 352-337-3915 (Fax)

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern: Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.

Timeline

Recall initiated: 2016-04-12
Terminated: 2019-07-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #146149. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.