—#92907

Product

SpeedPass Disposable Suture Lariat with Nitinol Wire 45 Degree Up, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904008. Used to pass suture through tissue.

FDA product code: MDM — Instrument, Manual, Surgical, General Use
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot numbers: 863940 and 863950.

Why it was recalled

The nitinol wire may be fractured or may have the potential to fracture making the suture lariat unusable and possibly delaying surgery.

Root cause (FDA determination)

Component design/selection

Action the firm took

The firm notified all 29 consignees by An Urgent Medical Device Recall Notice letter on 6/18/2010. The letter identified the affected product and explained the reason for recall. Customers are asked to locate and remove the affected products, follow the instructions on the enclosed "FAX Back Response Form," and fax a copy of the form back prior to return of the affected product. Additionally, if product has been further distributed, then hospital personnel must be notified and given the "Dear Biomet Customer" letter. Questions should be directed to Mary Johnson at 800-348-9500 or 574-372-3983.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- USA, including the states of FL, IL, NY, CO, MD, CA, GA, AL, PA, OH, SD, KY, TX, ID, WA, NC, AK, & MN, and Columbia and The Netherlands.

Timeline

Recall initiated: 2010-06-18
Posted by FDA: 2010-08-16
Terminated: 2012-08-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #92907. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.