Date Initiated by Firm |
February 12, 2008 |
Date Posted |
September 11, 2008 |
Recall Status1 |
Terminated 3 on June 30, 2009 |
Recall Number |
Z-1318-2008 |
Recall Event ID |
46707 |
Product Classification |
hip implant instrument - Product Code LXH
|
Product |
Biomet Orthopedics Echo Hip Instrumentation Exact Slotted Stem Inserter, Part number: 31-555610. |
Code Information |
Lots 218606, 218614 and 217595. |
Recalling Firm/ Manufacturer |
Biomet, Inc. 56 E Bell Dr Warsaw IN 46582
|
For Additional Information Contact |
800-348-9500
|
Manufacturer Reason for Recall |
The instrument will not mate with its stem.
|
FDA Determined Cause 2 |
Process control |
Action |
Biomet distributors were notified via recall letter dated 2/12/08 to locate the instruments in their possession and at hospital sites and to return them to Biomet. Hospitals with the instruments on hand will be provided with a recall letter dated 2/12/08 which describes the nature of the problem and the removal of these instruments. |
Quantity in Commerce |
78 |
Distribution |
Nationwide. |
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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