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U.S. Department of Health and Human Services

Class 2 Device Recall BioPro Femoral Head 28 mm 18

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 Class 2 Device Recall BioPro Femoral Head 28 mm 18see related information
Date Initiated by FirmSeptember 21, 2011
Date PostedNovember 04, 2011
Recall Status1 Terminated 3 on February 15, 2013
Recall NumberZ-0164-2012
Recall Event ID 60143
510(K)NumberK090208 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
ProductBioPro Femoral Head 28 mm +18, Item 19010. Orthopedic femoral head for implantation
Code Information Item 19010, Lot 108329, Serial Number 0001-0016;    
Recalling Firm/
Manufacturer		 Biopro, Inc.
2929 Lapeer Rd
Port Huron MI 48060-2558
For Additional Information ContactPatrick 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		Packaging
ActionBiopro, 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 Commerce8 units
DistributionUSA (nationwide) including the states of FL, MI, and TX.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JDI
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