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Toggleloc System, Biomet Ziptight Ankle Syndesmosis… recallZ-0559-2010 · Biomet, Inc. · initiated Nov 10, 2009

Terminated All recalls posted in December 2009

Is my device affected?

  1. 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.
  2. If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. 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

Packages labeled as containing a stainless steel device actually contain a titanium device, and vice versa.

FDA root cause category: Labeling mix-ups

What the company is doing

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.

Recall details

Recall number
Z-0559-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 10, 2009
Posted by the FDA
Dec 22, 2009
Recalling firm
Biomet, Inc.
Quantity
24 of both products.
Product code
MBI
FDA submissions
K083070
Distribution
Nationwide Distribution -- Including states of California, Florida, South Carolina, and Virginia.

Product description

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.

Code information (models, lots, serial numbers)

Lot 101780.

Other devices under the same FDA submission

9 devices cleared under K083070 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 53878).

Sources and updates

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