Product Wiki · Recalls · U.S. FDA — Device Enforcement

CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1… — recall Z-2879-2018

U.S. FDA — Device Enforcement · United States · 2018-07-16 · Class II

As described by U.S. FDA — Device Enforcement: 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

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2879-2018
Date of alert
2018-07-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
In2bones USA, LLC
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - US Nationwide and the countries of France
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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