| Class 2 Device Recall Femoral Stem | |
Date Initiated by Firm | April 12, 2016 |
Create Date | June 02, 2016 |
Recall Status1 |
Terminated 3 on July 24, 2019 |
Recall Number | Z-1904-2016 |
Recall Event ID |
73200 |
PMA Number | P050039 |
Product Classification |
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented - Product Code MRA
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Product | Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem; Catalog Number 160-10-16; For use in primary total hip arthroplasty. |
Code Information |
Product Codes: LPH, MEH, LWJ, JDI; Catalog Number 160-10-16, Serial Number: 4256338, Exp. 1/27/2021. |
Recalling Firm/ Manufacturer |
Exactech, Inc. 2320 NW 66th Ct Gainesville FL 32653-1630
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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 | 1 device. |
Distribution | Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI. |
Total Product Life Cycle | TPLC Device Report |
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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.
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PMA Database | PMAs with Product Code = MRA
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