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Biomet, Inc. recalls Black Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through
Recalled October 15, 2014 · FDA recall Z-0056-2015 · Biomet
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. · FDA Class II
Units
15 units
Sold at
Nationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR.
Description
An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.
Product
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.
Manufacturer(s)
Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →