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U.S. Department of Health and Human Services

Class 2 Device Recall BioPro Femoral Head 28 mm 6 mm

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  Class 2 Device Recall BioPro Femoral Head 28 mm 6 mm see related information
Date Initiated by Firm September 21, 2011
Date Posted November 04, 2011
Recall Status1 Terminated 3 on February 15, 2013
Recall Number Z-0163-2012
Recall Event ID 60143
510(K)Number K090208  
Product Classification Prothesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
Product BioPro Femoral Head 28 mm -6 mm, Item 19003.

Orthopedic femoral head for implantation.

Code Information Item 19003, Lot 108327, Serial Number 0007-0014;    
Recalling Firm/
Biopro, Inc.
2929 Lapeer Rd
Port Huron MI 48060-2558
For Additional Information Contact Patrick Pringle
810-982-7777 Ext. 101
Manufacturer Reason
for Recall
BioPro Femoral Head Outer Packaging was found lacking proper seal ,compromising sterility.
FDA Determined
Cause 2
Action Biopro, Inc notified all affected customers via telephone on September 21, 2011 with instructions to quarantine and return affected product to the manufacturer. The firm sent a follow up "RECALL NOTICE" dated September 29, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter gives instructions on how to return affected product. Contact Customer Service at 1-800-252-7707 for questions regarding this recall.
Quantity in Commerce 4 units
Distribution USA (nationwide) including the states of FL, MI, and TX.
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.
510(K) Database 510(K)s with Product Code = JDI and Original Applicant = BIOPRO, INC.