Atlas FDA

Biomet brand Modular Microplasty Cup Inserter, 3/8" thread, Biomet Orthopedics, Inc., Warsaw, IN; Model 31-400600. Non-p

FDA device recall Z-0181-2009 · posted 2008-10-24 · Terminated

Recall details

Recalling firm
Biomet, Inc.
Reason for recall
The pin and clip may fracture during use.
Action taken
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.
Root cause
Device Design
Status
Terminated
Product code
LXH
Quantity affected
85
Distribution
Nationwide, Australia, Belgium, Canada, Denmark, New Zealand and Sweden.
Date initiated
2008-07-28
Date posted
2008-10-24
Date terminated
2009-09-22
Location
Warsaw, IN

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