SpeedPass Disposable Suture Lariat with Nitinol Wire 45 Degree Up, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Ste

FDA device recall Z-2228-2010 · posted 2010-08-16 · Terminated

Recall details

Recalling firm

Biomet, Inc.

Reason for recall

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

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

MDM

Quantity affected

301 units total

Distribution

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.

Date initiated

2010-06-18

Date posted

2010-08-16

Date terminated

2012-08-06

Location

Warsaw, IN