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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet 8.0MM cannulated reamer for the Aimer system

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  Class 2 Device Recall Biomet 8.0MM cannulated reamer for the Aimer system see related information
Date Initiated by Firm August 06, 2009
Date Posted September 08, 2009
Recall Status1 Terminated 3 on October 06, 2010
Recall Number Z-2042-2009
Recall Event ID 52885
Product Classification Orthopedic Surgical Instrument Ac-Powered Motor and Accessories/Attachments - Product Code HWE
Product Biomet 8.0MM cannulated reamer for the Aimer system, Biomet Sports Medicine, Ontario, CA; REF 909618.
Code Information Lot 027410.
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582
For Additional Information Contact
800-348-9500
Manufacturer Reason
for Recall		 These surgical instruments are etched with incorrect measurement markings.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignees were notified by letter dated 8/6/09 to remove the instrument from use and to return the recalled instrument to Biomet. Implanting surgeons were notified by letter dated 8/6/09, advised of the problem and it was suggested that the patients be monitored for instability if deemed necessary by the surgeon.
Quantity in Commerce 2
Distribution Nationwide Distribution -- Including the state of Texas.
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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