Z-0123-2008
Biomet Orthopedics, Vanguard PS Open Box Femoral, 67.5 mm Left-Interlok, For Cemented Use Only, CO-CR-MO...
Zimmer GmbH / initiated 2007-08-31 / Terminated / root cause: packaging
Biomet, Inc. began a recall of Biomet Orthopedics, Vanguard PS Open Box Femoral, 67.5 mm Left-Interlok, For Cemented Use Only, CO-CR-MO Alloy, REF 183130, Knee Prosthesis Component, Biomet... on . The reason FDA records is "Mislabeled as to size; labeled as 67.5 mm, actually contains 62.5 mm size femoral component". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-0123-2008
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer GmbH
- Product
- Biomet Orthopedics, Vanguard PS Open Box Femoral, 67.5 mm Left-Interlok, For Cemented Use Only, CO-CR-MO Alloy, REF 183130, Knee Prosthesis Component, Biomet Orthopedics, Inc., Warsaw, IN 46581
- Product code
- JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Reason for recall
- Mislabeled as to size; labeled as 67.5 mm, actually contains 62.5 mm size femoral component.
- Root cause tag
- packaging
- FDA root cause
- Packaging process control
- Action
- Biomet notified consignees via letter dated 8/31/07, titled Urgent Medical Device Recall Notice to immediately discontinue use of the product and to return units to Biomet.
- Quantity in commerce
- 16
- Distribution
- Nationwide.
- Product codes and lots
- Lot Number: 395450.
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