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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Microplasty Cup Impactor

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  Class 2 Device Recall Biomet Microplasty Cup Impactor see related information
Date Initiated by Firm January 16, 2008
Date Posted August 20, 2008
Recall Status1 Terminated 3 on September 22, 2009
Recall Number Z-1187-2008
Recall Event ID 46345
Product Classification Instrument for hip prosthesis acetabular cup component. - Product Code LXH
Product Biomet Microplasty Cup Impactor, 1/4" -28 Thread Insert; Model 31-400605. Instrument for hip prosthesis acetabular cup component.
Code Information Lots: 095209, 095210, 096830, 096857 and 096858.
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46581-0587
For Additional Information Contact Mary Hardesty
800-348-9500
Manufacturer Reason
for Recall		 The weld at the lock location may fracture during impaction.
FDA Determined
Cause 2		 Device Design
Action Biomet notified distributors and medical facilities by letter dated 1/16/08. Distributors with distributor-owned instruments at medical facilities were notified by email on 1/17/08, and provided with a letter to present to their associated medical facilities describing the recall.
Quantity in Commerce 630
Distribution Worldwide Distribution: USA, Germany, Mexico, Netherlands, Sweden and United Kingdom.
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.
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