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.
FDA Recall Z-0057-2015 · Posted 2014-10-09
Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeHWQ
Date Initiated2014-09-26
Date Terminated2015-07-14
Product Quantity12 units
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.
Firm Action
On 9/26/2014, "URGENT MEDICAL DEVICE RECALL NOTICE" notifications were sent via courier to the affected distributors with instructions for returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, contact information, and instructions for responding to the formal recall notification.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.