FDA Device recall Z-0058-2015
Mamba Disposable Nitinol Needle
- FDA Device
- Class II
- terminated
- Published 2014-10-15
On 2014-10-15 the FDA classified a Class II recall of Mamba Disposable Nitinol Needle by Biomet, citing an investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0058-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-26 |
| Published | 2014-10-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet |
| Distribution | US |
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.
Identifiers
| code_info | Catalog Number: 110010851 Lot Number: 139800, 139810, 139820 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0058-2015%22
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