Recall Z-2880-2018— In2bones USA, LLC

Name: FDA recall Z-2880-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-16

Class II · Terminated

Class II FDA medical device recall by In2bones USA, LLC, initiated 2018-07-16, terminated 2019-02-22. It names one FDA 510(k) clearance: K163293. Product: CoLink(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.. Reason: 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..

Recalling firm: In2bones USA, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-07-16
Terminated: 2019-02-22
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K163293 — Colink Plating SystemIn2bones USA, LLC·cleared 2017-05-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CoLink(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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.