• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Femoral Stem

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall Femoral Stem 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-1905-2016
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 Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11, Femoral Stem; Catalog Number 160-30-11; For use in primary total hip arthroplasty.
Code Information Product Codes: LPH, MEH, LWJ, JDI; Catalog Number 160-30-11, Serial Numbers: 4273184, 4273185, 4273187, 4273188, 4273189, 4273190, 4273191, 4273192 and 4273186, Exp. 2/8/2021.
Recalling Firm/
Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Kaya Davis
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 9 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.