Recall Z-0056-2015 ยท HWQ Passer
Biomet, Inc.
Black 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.
| Date | Oct 9, 2014 (initiated Sep 26, 2014) |
| Status | Terminated |
| Reason | 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 | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 15 units |
| Distribution | Nationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.