Recall Z-2230-2010
Biomet, Inc. · initiated June 18, 2010
Product
SpeedPass Disposable Suture Lariat with Nitinol Wire 25 Degree Right, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904012. Used to pass suture through tissue.
Codes / lots: Lot numbers: 863920 and 863930.
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.
FDA-determined cause: Component design/selection
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.
Details
- Recall number
- Z-2230-2010
- Initiated
- June 18, 2010
- Posted by FDA
- August 16, 2010
- Terminated
- August 6, 2012
- Product code
- MDM – Instrument, Manual, Surgical, General Use
- Quantity
- 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.
- Recalling firm
- Biomet, Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2228-2010 | SpeedPass Disposable Suture Lariat with Nitinol Wire 45 Degree Up, QTY. 1, Biomet Sports…The nitinol wire may be fractured or may have the potential to fracture making the suture lariat unusable… | 06/18/2010Terminated |
| Z-2229-2010 | SpeedPass Disposable Suture Lariat with Nitinol Wire 25 Degree Left, QTY. 1, Biomet…The nitinol wire may be fractured or may have the potential to fracture making the suture lariat unusable… | 06/18/2010Terminated |
| Z-2231-2010 | Suture Lariat 30 Degree Up, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile.…The nitinol wire may be fractured or may have the potential to fracture making the suture lariat unusable… | 06/18/2010Terminated |
| Z-2232-2010 | Suture Lariat 45 Degree Dog Leg Up, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581.…The nitinol wire may be fractured or may have the potential to fracture making the suture lariat unusable… | 06/18/2010Terminated |