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U.S. Department of Health and Human Services

Class 2 Device Recall Maxim

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  Class 2 Device Recall Maxim see related information
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/
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact
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
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.