FDA recall Z-0104-2022

Product

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

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

Key facts

Status

Terminated

Initiation date

2021-09-08

Report date

2021-10-20

Termination date

2024-05-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Leesburg, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0104-2022