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U.S. Department of Health and Human Services

Class 2 Device Recall CoLink(TM) Lapidus Plate XP

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  Class 2 Device Recall CoLink(TM) Lapidus Plate XP see related information
Date Initiated by Firm July 16, 2018
Create Date August 21, 2018
Recall Status1 Terminated 3 on February 22, 2019
Recall Number Z-2879-2018
Recall Event ID 80618
510(K)Number K163293  
Product Classification Screw, fixation, bone - Product Code HWC
Product CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones

Product Usage:
The In2Bones USA LLC, CoLink¿ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
Code Information Lot Number 1704073
Recalling Firm/
Manufacturer		 In2bones USA, LLC
Attn: Tommy Turpin
6060 Poplar Ave Ste 380
Memphis TN 38119-3980
For Additional Information Contact Alan Taylor
901-849-0458
Manufacturer Reason
for Recall		 CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates.
FDA Determined
Cause 2		 Process control
Action In2Bones sent a Medical Device Recall letter dated July 18, 2018 to affected customers (agents and hospitals). The letter identified the affected product, problem and actions to be taken. The Agent notice requested the consignee to inform and distribute the notice to all relevant person within the organization. The firm is seeking the return of the products The notice to the hospitals and healthcare professionals explained the problem and recommended that patients be monitored for any adverse events within the normal standard of practice. For questions contact Quality and Regulatory Affairs Team at 901-260-7931..
Quantity in Commerce 47 units
Distribution Worldwide Distribution - US Nationwide and the countries of France
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 = HWC and Original Applicant = IN2BONESUSA, LLC
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