Date Initiated by Firm |
January 16, 2008 |
Date Posted |
August 20, 2008 |
Recall Status1 |
Terminated 3 on September 22, 2009 |
Recall Number |
Z-1186-2008 |
Recall Event ID |
46345 |
Product Classification |
Instrument for hip prosthesis acetabular cup component. - Product Code LXH
|
Product |
Biomet brand Modular Microplasty Cup Impactor, 3/8" - 24 Thread Insert; Model 31-400603. Instrument for hip prosthesis acetabular cup component. |
Code Information |
Lot 095207. |
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 |
59 |
Distribution |
Worldwide Distribution: USA, Germany, Mexico, Netherlands, Sweden and United Kingdom. |
Total Product Life Cycle |
TPLC Device Report
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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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