Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0104-2022

September 08, 2021

Class II

Product summary

Firm
K2M, Inc
Event
Event 88630
Status
Terminated
Classification
Class II
Quantity
23
Official record key
device-enforcement:Z-0104-2022

Official wording

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.

Code information: Lots CCUNA, HYMJ, KNCU

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.