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.
FDA Recall Z-1699-2009 · Posted 2009-07-23
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeJDI
Date Initiated2009-06-08
Date Terminated2009-12-15
Product Quantity133
Reason for Recall
The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility.
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution -- United States, Canada and Japan.
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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