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K2M, Inc Recall 88630

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

K2M, Inc Recall 88630 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0104-2022
Event ID88630
Event DescriptionChesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
Product TypeDevices
DistributionDomestic distribution to CO, IL, LA, MA, MS, OK, PA, TN, and TX. Foreign distribution to Columbia, UK, Netherlands, and Canada.
Recall ReasonUnits 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.
Device Classification20211020
Device Code InfoLots CCUNA, HYMJ, KNCU
Center Classification Date20211013
Recall Initiation Date20210908
Recalling FirmK2M, Inc
Initial Notification Letter
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