Recall Z-0058-2015— Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Biomet, Inc., initiated 2014-09-26, terminated 2015-07-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Mamba Disposable Nitinol Needle. 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: An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use..
- Recalling firm
- Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-26
- Terminated
- 2015-07-14
- Firm location
- Warsaw, IN, United States
Product description
Mamba Disposable Nitinol Needle. 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.