Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw… — Class II medical device recall Z-1410-2021
Terminated recall by K2M, Inc, reported 2021-04-21, distributed in PA. Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the inserters
| Recall number | Z-1410-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | K2M, Inc, Leesburg, VA, United States |
| Recall initiated | 2021-03-16 |
| Classified | 2021-04-12 |
| Reported by FDA | 2021-04-21 |
| Terminated | 2021-08-12 |
| Distributed | PA |
| Quantity | 1 units |
| UPC / GTIN / UDI-DI | 10888857082571 |
| Model numbers | 3608-90033 |
Product
Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033
Reason for recall
Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the inserters. As a result, inner shafts do not mate flush with the collet inserters, and splaying of the collet. If implant falls into the spinal cord may cause a spinal cord injury or Incomplete seating of the inserter to the implant could result in misalignment of the screws with the inserter screw guide, potentially causing malposition of the screws into the adjacent vertebral bodies
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-1410-2021. 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.