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U.S. Department of Health and Human Services

Class 2 Device Recall Acetabular Cup

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  Class 2 Device Recall Acetabular Cup see related information
Date Initiated by Firm April 12, 2016
Create Date June 02, 2016
Recall Status1 Terminated 3 on July 24, 2019
Recall Number Z-1901-2016
Recall Event ID 73200
PMA Number P050039 
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented - Product Code MRA
Product 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.
Code Information Product Code: MRA, Catalog Number 140-01-56, Serial Numbers: 4268399 and 4268400, Exp. 2/6/2021.
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Kaya Davis
352-377-1140
Manufacturer Reason
for Recall		 Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
FDA Determined
Cause 2		 Packaging process control
Action 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)
Quantity in Commerce 2 devices.
Distribution Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MRA and Original Applicant = EXACTECH, INC.
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