FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Toggleloc System, Biomet Ziptight Ankle Syndesmosis Fixation System - SS with Ziploop Technology, polyethylene/polypropylene/ polyester/ stainless steel, sterile Biomet Sports Medicine, Warsaw, IN.; REF 909857. A smooth or threaded metallic bone fixation fastener intended to be implanted for fixation of bone fractures.
- Recall number
- Z-0560-2010
- Recalling firm
- Biomet, Inc.
- Product
- Toggleloc System, Biomet Ziptight Ankle Syndesmosis Fixation System - SS with Ziploop Technology, polyethylene/polypropylene/ polyester/ stainless steel, sterile Biomet Sports Medicine, Warsaw, IN.; REF 909857. A smooth or threaded metallic bone fixation fastener intended to be implanted for fixation of bone fractures.
- Status
- Terminated
- Initiated
- 2009-11-10
- Posted
- 2009-12-22
- Terminated
- 2010-11-03
- Reason
- Packages labeled as containing a stainless steel device actually contain a titanium device, and vice versa.
- 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
- 24 of both products.
- Distribution
- Nationwide Distribution -- Including states of California, Florida, South Carolina, and Virginia.
- Lot, serial or model codes
- Lot 101840.
- 510(k) numbers
- ["K083070"]
- PMA numbers
- not on file
- Product code
- MBI
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28