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Terminated

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.

FDA Recall Z-0056-2015 · Posted 2014-10-09

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeHWQ
Date Initiated2014-09-26
Date Terminated2015-07-14
Product Quantity15 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.

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