| Class 2 Device Recall Ascent | |
Date Initiated by Firm | May 16, 2005 |
Date Posted | August 31, 2005 |
Recall Status1 |
Terminated 3 on September 08, 2005 |
Recall Number | Z-1451-05 |
Recall Event ID |
32124 |
Product Classification |
Instrument, Cutting, Orthopedic - Product Code HTZ
|
Product | Biomet Ascent SI knee instruments sliding femoral 4-in-1 block, medium, stainless steel; Ref. RD140631. |
Code Information |
Lots 061800, 300150, 191900, 192030, 542470, 439240, 443030, 481530, 608400, 024540, 278410 and 761860. |
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 | 170 |
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 |
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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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