FDA Device recall Z-0104-2022
Chesapeake Anterior Lumbar (AL) Removal Tool
- FDA Device
- Class II
- terminated
- Published 2021-10-20
On 2021-10-20 the FDA classified a Class II recall of Chesapeake Anterior Lumbar (AL) Removal Tool by K2m, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0104-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-09-08 |
| Published | 2021-10-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | K2m |
| Distribution | CO, IL, LA, MA, MS, OK, PA, TN, TX |
Product
Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
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.
Identifiers
| code_info | Lots CCUNA, HYMJ, KNCU |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0104-2022%22
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