—#142309

Product

Black Mamba Suture Passer

FDA product code: HWQ — Passer
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Catalog Number: 110010849 Lot Number Identification: 167880, 169620, 253190, 520810, 538490, 551550, 716270, 960180

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

On 12/2/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors and hospital risk managers via courier with instructions to locate and return the affected products. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

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

Timeline

Recall initiated: 2015-12-02
Terminated: 2016-10-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142309. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.