Z-0057-2015 Class II Terminated
FDA device recall Z-0057-2015 was initiated by Biomet, Inc. on Sep 26, 2014 and is designated Class II. 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. The recall status is terminated (terminated Jul 14, 2015). Affected quantity: 12 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 15, 2014
- Initiation Date
- Sep 26, 2014
- Termination Date
- Jul 14, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 units
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.
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.
Distribution Pattern
Nationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR.
Code Information
Catalog Number: 110010850 Lot Number: 231120, 253210
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0057-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026