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Artificial ligament fixation device # 7PE ZIPLOOP Extended… recallZ-1952-2010 · Biomet, Inc. · initiated Mar 31, 2010

Terminated All recalls posted in July 2010

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

The firm has received complaints that the saddle is too long. The saddle is supposed to be between 7/8 and 1 1/8 inches long. The saddle in the complaints was up to 1.9 inches long.

FDA root cause category: Process control

What the company is doing

Biomet Sports Medicine issued an "Urgent Medical Device Recall Notice" dated March 31, 2010 to user facilities and distributors. A second notification containing updated information was issued June 2, 2010. Consignees were instructed to discontinue use of the product and return it to the firm along with a completed Response Form. For further information, contact Biomet at 1-574-371-3755 or 1-574-371-3756, Monday through Friday, 8AM to 5PM.

Recall details

Recall number
Z-1952-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 31, 2010
Posted by the FDA
Jul 1, 2010
Recalling firm
Biomet, Inc.
Quantity
2466 both products
Product code
MBI
FDA submissions
K083070
Distribution
Worldwide Distribution -- United States, Canada, Australia, The Netherlands, Belgium, Italy, France, New Zealand, Austria, United Kingdom, Chile, Greece, Poland, Denmark, Turkey, Portugal, South Africa and Spain.

Product description

Artificial ligament fixation device # 7PE ZIPLOOP Extended Toggle, Sterile, REF 904755, Biomet Sports Medicine Warsaw, IN. Intended for soft tissue to bone fixation.

Code information (models, lots, serial numbers)

Lot Numbers: 047510, 050400, 050420, 089710, 089800, 182820, 192240, 192250, 192280, 219260, 219270, 219280, 228530, 228550, 228580, 228590, 228610, 228620, 295450, 361020, 361020, 392930, 392990, 483490, 483500, 529380, 527780, 529800, 529810, 582890, 582910, 627510, 648470, 648480, 671130, 671150, 671170, 671180, 671190, 671240, 706150, 706160, 782360, 782370, 821710, 821730, 943000, 943010, 943030, 952040, 952070 and 974140.

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 55776).

Sources and updates

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