The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0471-2016·Announced 2015-12-30

Biomet Black Mamba Suture Passer Recalled for Weld Defect

Biomet is recalling 50 Black Mamba Suture Passers because a weld defect may cause the instrument's jaw to fail to actuate properly.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a mechanical defect that could lead to procedural failure (jaw not actuating), which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Biomet, Inc. is recalling 50 units of the Black Mamba Suture Passer. The recall is due to a potential separation and insufficient weld between the spring and washer components. This defect may cause the weld to fracture, resulting in the instrument's jaw not actuating properly.

The affected units are identified by Catalog Number 110010849 and specific lot numbers: 167880, 169620, 253190, 520810, 538490, 551550, 716270, and 960180. The products were distributed in the following states: FL, NJ, WI, UT, TX, KY, KS, OH, GA, LA, AL, NY, NC, AR, MO, VA, CA, MN, IN, and HI.

Six complaints have been received regarding this issue, three of which reported a delay of up to 10 minutes. Healthcare providers should stop using the affected devices and contact Biomet for instructions on return or replacement.

The recalled product

Product
Black Mamba Suture Passer
Manufacturer
Biomet, Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
50

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • Catalog Number: 110010849 Lot Number Identification: 167880
  • 169620
  • 253190
  • 520810
  • 538490
  • 551550
  • 716270
  • 960180

Distribution

Distributed in 20 states:

Part of a larger recall action

This product is one of 2 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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