Suture Lariat 45 Degree Dog Leg Up, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904025. Used to pass suture through tissue.
FDA Recall Z-2232-2010 · Posted 2010-08-16
Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeMDM
Date Initiated2010-06-18
Date Terminated2012-08-06
Product Quantity301 units total
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.
Firm Action
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
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.