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U.S. Department of Health and Human Services

Class 2 Device Recall Trabecular Metal acetabular Augments

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  Class 2 Device Recall Trabecular Metal acetabular Augments see related information
Date Initiated by Firm April 06, 2010
Date Posted August 12, 2010
Recall Status1 Terminated 3 on October 21, 2011
Recall Number Z-2215-2010
Recall Event ID 55364
510(K)Number K061067  
Product Classification prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product Trabecular Metal acetabular revision system buttress augment size, 58, 00-4898-001-58, sterile, Zimmer Inc., Parsippany, NJ.

Usage: Implantable devices that are used to address bony deficiencies of the pelvic antebulum in revision total hip arthroplasty surgery.
Code Information 60492195, 60531077, 60530963, 60661414, 60712297, 60770942, 60796674, 60834367, 60990646 and 61324530.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
574-267-6131
Manufacturer Reason
for Recall		 The firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.
FDA Determined
Cause 2		 Packaging
Action The firm sent an "Urgent Device Removal" letter dated 4/6/2010. The consignees were instructed to inventory the products on hand and return the recalled product to the manufacturer. More information is available at 1-800-613-6131.
Quantity in Commerce 1972 all products
Distribution US, Germany, Brazil, Singapore, Canada, Australia, England, India, and Switzerland.
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 = LPH and Original Applicant = ZIMMER TRABECULAR
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