Zimmer Allen medullary cement plugs, 1 - 20 dia. flange/10 mm dia. core, 1 - 24 mm dia. flange/12 mm dia. core (polyethylene with barium sulfate) with inserter, sterile, Zimmer, Warsaw, Indiana; Catatog Number: 00801102001. Total joint arthroplasty to control, restrict, or impede the flow of cement. Larger plugs are useful in revision surgery where a wide, smooth Intramedullary canal must be plugged.
Recall
- Recall Number
- Z-1699-2009
- Event Number
- 52227
- Firm
- Zimmer Inc.
- FEI Number
- 1000220733
- Product Code
- JDI
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- June 8, 2009
- Posted
- July 23, 2009
- Terminated
- December 15, 2009
- Address
- 345 E Main St, Warsaw, IN, 46580-2746
Description
Zimmer Allen medullary cement plugs, 1 - 20 dia. flange/10 mm dia. core, 1 - 24 mm dia. flange/12 mm dia. core (polyethylene with barium sulfate) with inserter, sterile, Zimmer, Warsaw, Indiana; Catatog Number: 00801102001. Total joint arthroplasty to control, restrict, or impede the flow of cement. Larger plugs are useful in revision surgery where a wide, smooth Intramedullary canal must be plugged.
The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility.
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.
Worldwide Distribution -- United States, Canada and Japan.
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