FDA-Device2021-10-20Class II
Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
K2M, Inc
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.
Sold states
Domestic distribution to CO, IL, LA, MA, MS, OK, PA, TN, and TX. Foreign distribution to Columbia, UK, Netherlands, and Canada.
Affected count
23
Manufactured in
600 Hope Pkwy SE, N/A, Leesburg, VA, United States
Products
Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0104-2022Don't want to check this manually?
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