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U.S. Department of Health and Human Services

Class 2 Device Recall Mamba Disposable Nitinol Needle

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  Class 2 Device Recall Mamba Disposable Nitinol Needle see related information
Date Initiated by Firm September 26, 2014
Date Posted October 09, 2014
Recall Status1 Terminated 3 on July 14, 2015
Recall Number Z-0058-2015
Recall Event ID 69360
Product Classification Crimper, pin - Product Code HXQ
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.
Code Information Catalog Number: 110010851 Lot Number: 139800, 139810, 139820
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46581
For Additional Information Contact Audrey Daenzer
574-372-1570
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
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.
Quantity in Commerce 164 units
Distribution Nationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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