—#82570

Product

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 product code: JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K001733
Affected lot / code info: Lot Number: 61239672.

Why it was recalled

The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Worldwide Distribution -- United States, Canada and Japan.

Timeline

Recall initiated: 2009-06-08
Posted by FDA: 2009-07-23
Terminated: 2009-12-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82570. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.