Recall Z-0471-2016— Biomet, Inc.

Name: FDA recall Z-0471-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-02

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2015-12-02, terminated 2016-10-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Black Mamba Suture Passer. Reason: 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..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-12-02
Terminated: 2016-10-27
Firm location: Warsaw, IN, United States

Product description

Black Mamba Suture Passer

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.