Urgent Field Safety Notice For 1 Level Kit, Retractors/wires; Size Ø1.4 Mm (qty 4 By K2m, Inc.

Recall Summary K2M, Inc. is recalling 1 Level Kit retractors and wires (size 1.4mm, quantity 4) distributed in Germany and the EU due to a safety concern. This is a Class I recall, which indicates a serious potential health risk. The specific issue and affected patient population are not clearly detailed in the available information.

Recalling firm

Urgent Field Safety Notice for 1 Level Kit, Retractors/Wires; Size Ø1.4 mm (Qty 4 by K2M, Inc. , Download_Veroeffentlich

Product

s Tasks of the BfArM Risk assessment Field corrective actions Urgent Field Safety Notice for 1 Level Kit, Retractors/Wires; Size Ø1

Reason

assessment Field corrective actions Urgent Field Safety Notice for 1 Level Kit, Retractors/Wires; Size Ø1

Classification

Class I

Category

medical device recall

Country

Germany

Agency

BFARM

Recall date

2026-04-17

Status

Ongoing

Distribution

Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/9650f44d-3628-4a6d-9d7c-336cb7e3f8f0