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 |
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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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