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Class 2 Device Recall Biomet brand Modular Microplasty Cup Inserter |
 |
| Date Initiated by Firm |
July 28, 2008 |
| Date Posted |
October 24, 2008 |
| Recall Status1 |
Terminated 3 on September 22, 2009 |
| Recall Number |
Z-0181-2009 |
| Recall Event ID |
49464 |
| Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
|
| Product |
Biomet brand Modular Microplasty Cup Inserter, 3/8" thread, Biomet Orthopedics, Inc., Warsaw, IN; Model 31-400600. Non-powered, hand-held instrument intended for use as an impactor during orthopedic surgery. |
| Code Information |
Lot 097525, 097526, 532370 and 532810. |
Recalling Firm/
Manufacturer |
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582
|
| For Additional Information Contact |
800-348-9500 Ext. 1501
|
Manufacturer Reason
for Recall |
The pin and clip may fracture during use.
|
FDA Determined
Cause 2 |
Device Design |
| Action |
Consignees were notified by recall letter dated 7/28/08 to remove the recalled lots from use and to return them. Contact Biomet, Inc. at 1-800-348-9500 or 1- 574-372-3983 for assistance. |
| Quantity in Commerce |
85 |
| Distribution |
Nationwide, Australia, Belgium, Canada, Denmark, New Zealand and Sweden. |
| 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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