Recall Z-0104-2022— K2M, Inc

Name: FDA recall Z-0104-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-08

Class II · Terminated

Class II FDA medical device recall by K2M, Inc, initiated 2021-09-08, terminated 2024-05-17. It names one FDA 510(k) clearance: K142487. Product: Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068. Reason: Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery..

Recalling firm: K2M, Inc
Classification: Class II
Status: Terminated
Initiated: 2021-09-08
Terminated: 2024-05-17
Firm location: Leesburg, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K142487 — Chesapeake Stabilization SystemK2m, Inc.·cleared 2015-05-07

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

Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068

Reason for recall

Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery.

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