Biomet, Inc. recalls Black Mamba Suture Passer

Recall date

December 2, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0471-2016

FDA classification

Class II

Brand / firm

Biomet, Inc.

Sold / distributed

FL, NJ, WI, UT, TX, KY, KS, OH, GA, LA, AL, NY, NC, AR, MO, VA, CA, MN, IN, HI

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Black Mamba Suture Passer