| |
Class 2 Device Recall Maxim |
 |
| Date Initiated by Firm |
May 16, 2005 |
| Date Posted |
August 31, 2005 |
| Recall Status1 |
Terminated 3 on September 08, 2005 |
| Recall Number |
Z-1454-05 |
| Recall Event ID |
32124 |
| Product Classification |
Instrument, Cutting, Orthopedic - Product Code HTZ
|
| Product |
Biomet Maxim SI knee instruments sliding femoral 4-in-1 block 55 mm, stainless steel; Ref. RD140529. |
| Code Information |
Lots 140370, 007450, 165140, 104620 and 458200. |
Recalling Firm/
Manufacturer |
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
|
| For Additional Information Contact |
800-348-9500
|
Manufacturer Reason
for Recall |
The instrument may have been assembled improperly, which may result in reversed resection cuts on the femur and affect implant performance, resulting in the need for revision surgery.
|
FDA Determined
Cause 2 |
Other |
| Action |
Biomet distributors were issued a letter dated 5/16/05 instructing them to locate the instruments and conduct a field inspection of the instruments to verify the pin location offset and ensure the correct orientation of the anterior marking on the slide component. |
| Quantity in Commerce |
46 |
| Distribution |
Nationwide, Australia, Austria, Belgium, Canada, Costa Rica, Denmark, Finland, Greece, Israel, Japan, Mexico, Netherlands, New Zealand, South Korea, Spain, and the United Kingdom. |
| 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.
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