Z-1699-2009

Zimmer Allen medullary cement plugs, 1 - 20 dia. flange/10 mm dia. core, 1 - 24 mm dia. flange/12 mm dia...

Name: Z-1699-2009 Zimmer Allen medullary cement plugs, 1 - 20 dia. flange/10 mm dia. core, 1 - 24 mm dia. flange/12 mm dia...
Creator: Zimmer Inc.
Published: 2009-06-08
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-06-08 / Terminated / root cause: packaging

FDA source

Zimmer Inc. began a recall of 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... on 2009-06-08. The reason FDA records is "The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1699-2009
Status: Terminated
Initiated: 2009-06-08
Posted: 2009-07-23
Terminated: 2009-12-15
Recalling firm: Zimmer GmbH
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.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility.
Root cause tag: packaging
FDA root cause: Packaging process control
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.
Quantity in commerce: 133
Distribution: Worldwide Distribution -- United States, Canada and Japan.
Product codes and lots: Lot Number: 61239672.

Product code JDI

K001733Class IIAllen Medullary Cement Plugs, Zimmer Poly Plug Intramedullary System, Model 8011 Series & 1109 & 8109 SeriesZimmer, Inc. / cleared 2000-06-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)