Biomet, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0057-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.
Product Description:

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.

Product Classification:

Class II

Date Initiated: September 26, 2014
Date Posted: October 15, 2014
Recall Number: Z-0057-2015
Event ID: 69360
Reason for Recall:

An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.

Status: Terminated
Product Quantity: 12 units
Code Information:

Catalog Number: 110010850 Lot Number: 231120, 253210

Distribution Pattern:

Nationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR.

Voluntary or Mandated:

Voluntary: Firm initiated