Z-1700-2009
Zimmer Coonrad/Morrey total elbow cement restrictor with nozzle, 1 - 16 mm, 1 - 25 mm, sterile, Zimmer...
Zimmer GmbH / initiated 2009-06-08 / Terminated / root cause: packaging
Zimmer Inc. began a recall of Zimmer Coonrad/Morrey total elbow cement restrictor with nozzle, 1 - 16 mm, 1 - 25 mm, sterile, Zimmer, Dover, Ohio; Catatog Number: 32810503800. Total joint... on . The reason FDA records is "The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-1700-2009
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer GmbH
- Product
- Zimmer Coonrad/Morrey total elbow cement restrictor with nozzle, 1 - 16 mm, 1 - 25 mm, sterile, Zimmer, Dover, Ohio; Catatog Number: 32810503800. Total joint arthroplasy to control, restrict or impede the flow of cement. Larger plugs are useful in revision surgery where a wide, smooth Imtramedullary canal must be plugged.
- Product code
- JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Reason for recall
- The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility.
- Root cause tag
- packaging
- FDA root cause
- Packaging process control
- Action
- Zimmer Orthopedic Surgical Products issued an "Urgent: Medical Device Recall" notice dated June 8, 2009 informing users of the affected devices and actions to be taken including the return of product and acknowledgement of receipt of notice by returning the Recall Certification Form by fax to 1-330-364-0974.
- Quantity in commerce
- 110
- Distribution
- Worldwide Distribution -- United States, Canada and Japan.
- Product codes and lots
- Lot Numbers: 61249897 and 61249899.
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