Z-0993-2007

Graft Preparation System, sterile, single use, disposable, Distributed by Biomet Biologics, Inc., Warsaw...

Name: Z-0993-2007 Graft Preparation System, sterile, single use, disposable, Distributed by Biomet Biologics, Inc., Warsaw...
Creator: Biomet, Inc.
Published: 2007-06-11
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2007-06-11 / Terminated

FDA source

Biomet, Inc. began a recall of Graft Preparation System, sterile, single use, disposable, Distributed by Biomet Biologics, Inc., Warsaw, Indiana; REF 800-0300 on 2007-06-11. The reason FDA records is "The syringe assembly has an obstruction in the tube that prevents the plunger from being depressed". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0993-2007
Status: Terminated
Initiated: 2007-06-11
Posted: 2007-07-04
Terminated: 2007-12-05
Recalling firm: Zimmer GmbH
Product: Graft Preparation System, sterile, single use, disposable, Distributed by Biomet Biologics, Inc., Warsaw, Indiana; REF 800-0300.
Product code: FMF Syringe, Piston
Reason for recall: The syringe assembly has an obstruction in the tube that prevents the plunger from being depressed.
FDA root cause: Other
Action: Consignees were notified by letter dated either 6/11/07 or 6/13/07 and requested to return the product.
Quantity in commerce: 46 to U.S. and international
Distribution: Worldwide, including USA, Chile, Italy, Spain and United Kingdom.
Product codes and lots: Lots 192180, exp. Jan 2012; 223260, exp. Jan 2012 and 652330, exp May 2011.

Product code FMF

K021071Class IIPccs Graft Delivery SystemBiomet, Inc. / cleared 2002-07-01

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)