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K2M, Inc recalls Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
Recalled October 20, 2021 · FDA recall Z-0104-2022 · K2M
Hazard
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. · FDA Class II
Units
23
Sold at
Domestic distribution to CO, IL, LA, MA, MS, OK, PA, TN, and TX. Foreign distribution to Columbia, UK, Netherlands, and Canada.
Description
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.
Product
Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
Manufacturer(s)
K2M, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →