The Recall Desk
HighFDA (Devices)·Z-0056-2015·Announced 2014-10-15

Biomet Black Mamba Suture Passer Recalled Due to Needle Breakage Risk

Biomet, Inc. is recalling 15 units of Black Mamba Suture Passers because high friction may cause the needle to break during use.

What this means for you

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 risk-of-harm product (needle breakage) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Biomet, Inc. is recalling 15 units of the Black Mamba Suture Passer. The product is a sterile, disposable medical instrument used to pass suture through soft tissue. The needles are designed for single-patient use only.

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 affected units are identified by Catalog Number 110010849 and Lot Numbers 169620 and 253190.

The recalled 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 should stop using these specific units and contact Biomet, Inc. for instructions on return or replacement.

The recalled product

Product
Black 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
15

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: 110010849 Lot Number: 169620
  • 253190

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 →

Related recalls

Same manufacturer · Biomet, Inc.

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Same hazard · needle breakage

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