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Biomet, Inc. recalls Green Mamba Suture Passer
Recalled December 30, 2015 · FDA recall Z-0472-2016 · Biomet
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. · FDA Class II
Units
13
Sold at
FL, NJ, WI, UT, TX, KY, KS, OH, GA, LA, AL, NY, NC, AR, MO, VA, CA, MN, IN, HI
Description
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.
Product
Green Mamba Suture Passer
Manufacturer(s)
Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →