Recalls / —
—#130294
Product
Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
- FDA product code
- HWQ — Passer
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- Catalog Number: 110010850 Lot Number: 231120, 253210
Why it was recalled
An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
On 9/26/2014, "URGENT MEDICAL DEVICE RECALL NOTICE" notifications were sent via courier to the affected distributors with instructions for returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, contact information, and instructions for responding to the formal recall notification.
Recalling firm
- Firm
- Biomet, Inc.
- Address
- 56 E Bell Dr, Warsaw, Indiana 46581
Distribution
- Distribution pattern
- Nationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR.
Timeline
- Recall initiated
- 2014-09-26
- Posted by FDA
- 2014-10-09
- Terminated
- 2015-07-14
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #130294. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.