Zimmer Inc. 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Zimmer Inc.
Lot Codes / Batch Numbers
Lot Number: 61239672.
Products Sold
Lot Number: 61239672.
Zimmer Inc. is recalling Zimmer Allen medullary cement plugs, 1 - 20 dia. flange/10 mm dia. core, 1 - 24 mm dia. flange/12 mm due to The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026