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Recall Observatory FDA recall evidence

Device product

Green Mamba Suture Passer

Z-0472-2016

December 02, 2015

Class II

Product summary

Firm
Biomet, Inc.
Event
Event 72829
Status
Terminated
Classification
Class II
Quantity
13
Official record key
device-enforcement:Z-0472-2016

Official wording

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.

Code information: Catalog Number: 110010850 Lot Number Identification: 167890, 231120, 253210, 550050, 551580, 716300, 953230

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.