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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-2217-2010
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 column buttress right posterior/left anterior, 00-4894-400-00, sterile, Zimmer Inc., Parsippany, NJ.
Code Information 60492197, 60704071, 60667465, 60728122, 60770944, 60796679, 60862513, 61081548, 61143008, and 61324533.
Recalling Firm/
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
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
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 1,972 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