Health product recall

HALO PKS Cutting Forceps

Brand(s)
Last updated

Summary

Product
HALO PKS Cutting Forceps
Issue
Medical devices - Performance issue
What to do

OLYMPUS CANADA INC. TO  RECALL.CANADA@OLYMPUS.COM

Audience
Healthcare

Affected products

Affected Products

Lot or serial number

Model or catalog number

HALO PKS Cutting Forceps

More than 10 numbers, contact manufacturer.

PK-CF0533

Issue

Olympus has received eighteen (18) complaints for this issue, and sixteen (16) of these complaints were reported as serious injuries. The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure. Through our investigation, Olympus has determined that the issue impacts lots manufactured between March 2022 to December 2023.

Recall Start Date: January 19, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies

Gyrus Acmi, Inc

9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74987

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