FDA-Device2014-10-15Class II
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.
Biomet, Inc.
Hazard
An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.
Sold states
Nationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR.
Affected count
15 units
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0056-2015Don't want to check this manually?
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