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U.S. Department of Health and Human Services

Class 2 Device Recall NeoSpan SuperElastic Compression Staple with Instruments

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  Class 2 Device Recall NeoSpan SuperElastic Compression Staple with Instruments see related information
Date Initiated by Firm November 14, 2018
Create Date December 22, 2018
Recall Status1 Terminated 3 on May 08, 2019
Recall Number Z-0670-2019
Recall Event ID 81655
510(K)Number K161426  
Product Classification Staple, fixation, bone - Product Code JDR
Product NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010
Code Information Lot Number: 9G88C0
Recalling Firm/
In2bones USA, LLC
6060 Poplar Ave Ste 380
Memphis TN 38119-3915
For Additional Information Contact Alan Taylor
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Employee error
Action The firm initiated the recall by letter on 11/14/2018. The letter requested the return of the product.
Quantity in Commerce 30 units
Distribution TX, VA, PA, MO, NJ, FL, TN, NC, OH, WI, LA
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.
510(K) Database 510(K)s with Product Code = JDR and Original Applicant = IN2BONESUSA, LLC