FDAClass IIOctober 15, 2014

Mamba Disposable Nitinol Needle. The Biomet Sports recall

Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba…

Why was Mamba Disposable Nitinol Needle. The Biomet Sports recalled?

An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog Number: 110010851 Lot Number: 139800, 139810, 139820

Product
Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba…
Recalling firm
Biomet, Inc.
Quantity
164 units
Distribution
Nationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR.
Recall date
October 15, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls