Device product
Mamba Disposable Nitinol Needle. 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.
Z-0058-2015
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 69360
- Status
- Terminated
- Classification
- Class II
- Quantity
- 164 units
- Official record key
device-enforcement:Z-0058-2015
Official wording
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.
Code information: Catalog Number: 110010851 Lot Number: 139800, 139810, 139820
Distribution pattern: Nationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR.
Derived failure modes
-
Unknown
An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.