Home / Recalls / K2M, Inc / Z-0104-2022

Z-0104-2022 Class II Terminated

Recalled by K2M, Inc — Leesburg, VA

Recall Details

Product Type
Devices
Report Date
October 20, 2021
Initiation Date
September 8, 2021
Termination Date
May 17, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
23

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.

Distribution Pattern

Domestic distribution to CO, IL, LA, MA, MS, OK, PA, TN, and TX. Foreign distribution to Columbia, UK, Netherlands, and Canada.

Code Information

Lots CCUNA, HYMJ, KNCU

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