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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 XPsee related information
Date Initiated by FirmJuly 16, 2018
Create DateAugust 21, 2018
Recall Status1 Terminated 3 on February 22, 2019
Recall NumberZ-2880-2018
Recall Event ID 80618
510(K)NumberK163293 
Product Classification Screw, fixation, bone - Product Code HWC
ProductCoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, 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 1704075
Recalling Firm/
Manufacturer		 In2bones USA, LLC
Attn: Tommy Turpin
6060 Poplar Ave Ste 380
Memphis TN 38119-3980
For Additional Information ContactAlan 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
ActionIn2Bones 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 Commerce48 units
DistributionWorldwide Distribution - US Nationwide and the countries of France
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HWC
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