Vanguard PS Open Box Femoral 70 MM Left Interlock, " FOR CEMENTED USE ONLY" CO-CR-MO ALLOY. Biomet, Inc. A knee joint replacement prosthesis non-coated femoral indicated for cemented application only.
FDA Recall Z-2945-2011 · Posted 2011-08-04
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Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2011-07-06
Date Terminated2012-09-26
Product Quantity8
Reason for Recall
The recalled device was manufactured with two distal pegs but package labeling indicates the device is pegless.
Firm Action
Biomet Orthopedics sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter to all affected customers.
The letter included: reason for the recall, risks associated with use of the device, and alternate instructions for use of the recalled device. Customers are instructed to quarantine and return the devices, and a return form.
For information or questions on this recall call Biomet at (574) 371-3756.
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution: (USA) Nationwide including the states of NJ, PA, LA, SD, TX, and KS; and the country of The Netherlands.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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