|
Class 2 Device Recall Biomet Dual Offset Broach Handle, Clamping Style |
|
Date Initiated by Firm |
March 31, 2009 |
Date Posted |
June 01, 2009 |
Recall Status1 |
Terminated 3 on December 23, 2009 |
Recall Number |
Z-1352-2009 |
Recall Event ID |
51693 |
Product Classification |
orthopedic instrument - Product Code LXH
|
Product |
Biomet Dual Offset Broach Handle, Clamping Style, Left, REF 31-555403. For use in primary hip arthroplasty. |
Code Information |
Lots 066960, 141030, 147350, 316150, 401870, 401890, 523100, 604190, 829920, 899350 and 901600. |
Recalling Firm/ Manufacturer |
Biomet, Inc. 56 E Bell Dr Warsaw IN 46582
|
For Additional Information Contact |
Mary Johnson 574-372-3983
|
Manufacturer Reason for Recall |
The handle body may fracture or crack at the slot where the locking lever is inserted to clamp down onto the broach.
|
FDA Determined Cause 2 |
Device Design |
Action |
Biomet notified their distributors by recall letter dated 3/31/09, instructed them to pick up the insturments at the hospitals and to notify the hospital personnel of this recall action in writing. |
Quantity in Commerce |
178 of all products. |
Distribution |
Nationwide, Canada and Finland. |
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.
|
|
|
|