Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2299-2008

Zimmer Metasul Head 32/-4'S', taper 12/14, hip implant component; REF 19.32.05

Zimmer GmbH / initiated 2008-06-30 / Terminated / root cause: packaging

Zimmer Inc. began a recall of Zimmer Metasul Head 32/-4'S', taper 12/14, hip implant component; REF 19.32.05 on . The reason FDA records is "The wrong part may be in the package. Package may contain a 28 mm head". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-2299-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Zimmer GmbH
Product
Zimmer Metasul Head 32/-4'S', taper 12/14, hip implant component; REF 19.32.05.
Product code
KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Reason for recall
The wrong part may be in the package. Package may contain a 28 mm head.
Root cause tag
packaging
FDA root cause
Packaging process control
Action
Zimmer notified consignees via recall letter dated 6/20/08 to return the product.
Quantity in commerce
4
Distribution
Florida, Pennsylvania, Texas and Virginia.
Product codes and lots
Lot 2299218.