| Class 2 Device Recall Biomet Vanguard Instruments LockOn Femoral Impactor | |
Date Initiated by Firm | December 01, 2009 |
Date Posted | January 15, 2010 |
Recall Status1 |
Terminated 3 on October 18, 2010 |
Recall Number | Z-0646-2010 |
Recall Event ID |
53945 |
Product Classification |
Orthopedic Manual Surgical Instrument - Product Code LXH
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Product | Biomet Vanguard Lock-On Femoral Impactor, Biomet Orthopedics. Warsaw. IN; REF 32-486206.
Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery; impactor. |
Code Information |
Lots 122890, 296900, 424590, 433560, 433570, 433580, 433590, 433600, 646610 and 943990. |
Recalling Firm/ Manufacturer |
Biomet, Inc. 56 E Bell Dr Warsaw IN 46582
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For Additional Information Contact | 800-348-9500 |
Manufacturer Reason for Recall | The locking hook tabs may fracture and fragments remain in the patient post-operatively. |
FDA Determined Cause 2 | Device Design |
Action | Urgent Medical Device Recall Notices were sent to distributors on 12/01/2009 with a notice for them to provide to medical facilities where distributor-owned inventory is stored. Distributors were instructed to immediately locate and remove the instruments from circulation; follow the instructions on the "FAX Back Response Form" and fax a copy back prior to returning the product; and to return the product to the firm. Questions should be directed to 800-348-9500. |
Quantity in Commerce | 92 |
Distribution | Worldwide Distribution -- USA, Canada, China, Costa Rica, Denmark, Germany, Netherlands, New Zealand, and 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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