The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0057-2015·Announced 2014-10-15

Biomet Recalls Green Mamba Suture Passers Due to Needle Breakage Risk

Biomet, Inc. is recalling 12 units of Green Mamba Suture Passers because high friction may cause the needle to break during use.

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 risk of harm (needle breakage) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

Biomet, Inc. is recalling 12 units of the Green Mamba Suture Passer. The affected products are sterile, disposable, single-patient use instruments designed to aid in passing suture through soft tissue. The recall involves specific catalog and lot numbers identified in the agency's records.

The recall was initiated after an investigation identified that high-level friction may exist between the needle and the Mamba suture passer instrument. This friction can cause the needle to break during use. The products were distributed nationwide, including in Florida, New York, Texas, Virginia, Nevada, Michigan, California, Indiana, South Dakota, Georgia, Kentucky, North Carolina, and Arkansas.

Healthcare providers and patients who have used or possess these specific units should stop using them immediately. Users should contact Biomet, Inc. for instructions on how to return the devices or obtain a replacement, as directed by the recalling firm.

The recalled product

Product
Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
Manufacturer
Biomet, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
12

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 (2)

  • Catalog Number: 110010850 Lot Number: 231120
  • 253210

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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