Zimmer Allen medullary cement plugs, 1 - 20 dia. flange/10… recallZ-1699-2009 · Zimmer Inc. · initiated Jun 8, 2009
Terminated All recalls posted in July 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zimmer Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility.
FDA root cause category: Packaging process control
What the company is doing
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.
Recall details
- Recall number
- Z-1699-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 8, 2009
- Posted by the FDA
- Jul 23, 2009
- Recalling firm
- Zimmer Inc.
- Quantity
- 133
- Product code
- JDI
- FDA submissions
- K001733
- Distribution
- Worldwide Distribution -- United States, Canada and Japan.
Product 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.
Code information (models, lots, serial numbers)
Lot Number: 61239672.
Other devices under the same FDA submission
3 devices cleared under K001733 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA 8011-20-32Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths2 reports
- NA 8011-20-16Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- NA 8011-20-20Zimmer, Inc. · CEMENT OBTURATOR1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 52227).
- Z-1700-2009 · TerminatedZimmer 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 contro…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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