FDA Device recall Z-1410-2021
Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catal…
- FDA Device
- Class II
- terminated
- Published 2021-04-21
On 2021-04-21 the FDA classified a Class II recall of Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catal… by K2m, citing 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 inserte….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1410-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-16 |
| Published | 2021-04-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | K2m |
| Distribution | PA |
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
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
Identifiers
| code_info | Lot Number: MNAJ GTIN: 10888857082571 |
|---|
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-1410-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.