Z-0559-2010

Toggleloc System, Biomet Ziptight Ankle Syndesmosis Fixation System - Titanium with Ziploop Technology...

Name: Z-0559-2010 Toggleloc System, Biomet Ziptight Ankle Syndesmosis Fixation System - Titanium with Ziploop Technology...
Creator: Biomet, Inc.
Published: 2009-11-10
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-11-10 / Terminated / root cause: labeling and UDI

FDA source

Biomet, Inc. began a recall of Toggleloc System, Biomet Ziptight Ankle Syndesmosis Fixation System - Titanium with Ziploop Technology, polyethylene/polypropylene/ polyester/TI-6AL-4V... on 2009-11-10. The reason FDA records is "Packages labeled as containing a stainless steel device actually contain a titanium device, and vice versa". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0559-2010
Status: Terminated
Initiated: 2009-11-10
Posted: 2009-12-22
Terminated: 2010-11-03
Recalling firm: Zimmer GmbH
Product: Toggleloc System, Biomet Ziptight Ankle Syndesmosis Fixation System - Titanium with Ziploop Technology, polyethylene/polypropylene/ polyester/TI-6AL-4V alloy/S.S., sterile Biomet Sports Medicine, Warsaw, IN.; REF 909853. A smooth or threaded metallic bone fixation fastener intended to be implanted for fixation of bone fractures.
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: Packages labeled as containing a stainless steel device actually contain a titanium device, and vice versa.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Distributors, hospital consignees and an implanting surgeon were notified of the recall by an Urgent Medical Device Recall Notice, dated 11/10/09. Distributors were instructed to locate and remove the identified products from circulation. The instructions on the enclosed "FAX Back Response Form" should be followed and product from their accounts should be returned. Hospital consignees and the implanting surgeon were informed of the recall and advised of the potential health hazards presented by the mix-up.
Quantity in commerce: 24 of both products.
Distribution: Nationwide Distribution -- Including states of California, Florida, South Carolina, and Virginia.
Product codes and lots: Lot 101780.

Product code MBI

K083070Class IIToggleloc SystemBiomet Sports Medicine / cleared 2008-12-16

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)