Chesapeake Anterior Lumbar — Class II medical device recall Z-0104-2022
Terminated recall by K2M, Inc, reported 2021-10-20, distributed in CO, IL, LA, MA, MS, OK, PA, TN…. Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument durin
| Recall number | Z-0104-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | K2M, Inc, Leesburg, VA, United States |
| Recall initiated | 2021-09-08 |
| Classified | 2021-10-13 |
| Reported by FDA | 2021-10-20 |
| Terminated | 2024-05-17 |
| Distributed | CO, IL, LA, MA, MS, OK, PA, TN, TX |
| Countries outside the US | CA, GB, NL |
| Quantity | 23 |
| Model numbers | 2008-90068 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0104-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.