Class 2 Device Recall NeoSpan SuperElastic Compression Staple with Instruments

• Date Initiated by Firm: November 14, 2018
• Create Date: December 22, 2018
• Recall Status: Terminated 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/ Manufacturer: In2bones USA, LLC; 6060 Poplar Ave Ste 380; Memphis TN 38119-3915
• For Additional Information Contact: Alan Taylor ; 901-849-0458
• 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: 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