—#91756

Product

Toggleloc Artificial ligament fixation device ZIPLOOP Technology Implant Kit, Sterile, REF 909848, Biomet Sports Medicine Warsaw, IN. Intended for soft tissue to bone fixation.

FDA product code: MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K083070
Affected lot / code info: Lot Numbers: 228150, 228160, 783930, 975220, 975230 and 975240.

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-03-31
Posted by FDA: 2010-07-01
Terminated: 2012-08-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #91756. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.