FDAClass IIJanuary 2, 2019

NeoSpan SuperElastic Compression Staple w/Instruments recall

NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010

Why was NeoSpan SuperElastic Compression Staple w/Instruments recalled?

The NeoSpan Compression Staple (10x10x10) kits from two lots contain the wrong size drill bit. They contain a 3mm drill bit instead of a 2mm drill bit.

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?

Lot Number: 9G88C0

Product
NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010
Recalling firm
In2bones USA, LLC
Quantity
30 units
Distribution
TX, VA, PA, MO, NJ, FL, TN, NC, OH, WI, LA
Recall date
January 2, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls