FDA-Device2015-12-30Class II
Black Mamba Suture Passer
Biomet, Inc.
Hazard
There may be a separation and an insufficient weld between the spring and washer. The weld between the spring and washer may fracture, causing the Mamba Suture Passer instruments jaw to not actuate properly. 6 complaints have been received in which 3 have been reported with a delay up to 10 minutes.
Sold states
FL, NJ, WI, UT, TX, KY, KS, OH, GA, LA, AL, NY, NC, AR, MO, VA, CA, MN, IN, HI
Affected count
50
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Black Mamba Suture Passer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0471-2016Don't want to check this manually?
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