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.
Reported: October 15, 2014 Initiated: September 26, 2014 #Z-0057-2015
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.
Details
- Recalling Firm
- Biomet, Inc.
- Units Affected
- 12 units
- Distribution
- Nationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Biomet, Inc.. Units affected: 12 units.
Why was this product recalled? ▼
An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 15, 2014. Severity: Moderate. Recall number: Z-0057-2015.
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