Black Mamba Suture Passer (Biomet) – Needle Friction (2014)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Biomet, Inc.
Lot Codes / Batch Numbers
Catalog Number: 110010849 Lot Number: 169620, 253190
Products Sold
Catalog Number: 110010849 Lot Number: 169620, 253190
Biomet, Inc. is recalling Black Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in pa due to An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break duri. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026