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U.S. Department of Health and Human Services

Class 2 Device Recall Black Mamba Suture Passer

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 Class 2 Device Recall Black Mamba Suture Passersee related information
Date Initiated by FirmSeptember 26, 2014
Date PostedOctober 09, 2014
Recall Status1 Terminated 3 on July 14, 2015
Recall NumberZ-0056-2015
Recall Event ID 69360
Product Classification Passer - Product Code HWQ
ProductBlack 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.
Code Information Catalog Number: 110010849  Lot Number: 169620, 253190
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46581
For Additional Information ContactAudrey 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
ActionOn 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 Commerce15 units
DistributionNationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR.
Total Product Life CycleTPLC 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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