Public recall detail

24.0mm, 35.0mm, And 45.0 Mm Acutrak 2 4.7 Screws

2025-01-29

medium
Recall Safety notice
Quick summary

Quick summary: 24.0mm, 35.0mm, And 45.0 Mm Acutrak 2 4.7 Screws. Date: 2025-01-29.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: 24.0mm, 35.0mm, And 45.0 Mm Acutrak 2 4.7 Screws. Date: 2025-01-29.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandAcumed, LLC
Product24.0mm, 35.0mm, And 45.0 Mm Acutrak 2 4.7 Screws
IssueMedical devices - Performance
Recall classType II
IdentificationRA-76880

Affected products

Product24.0mm Acutrak 2 – 4.7 Screw
Lot619496
Model30-0624
Serial number619496
Description24.0mm Acutrak 2 – 4.7 Screw
Product35.0mm Acutrak 2 – 4.7 Screw
Lot640388
Model30-0635
Serial number640388
Description35.0mm Acutrak 2 – 4.7 Screw
Product45.0mm Acutrak 2 – 4.7 Screw
Lot620722
Model30-0645
Serial number620722
Description45.0mm Acutrak 2 – 4.7 Screw

Issue

Three different sizes of Acumed's Acutrak 2 system screws were identified to have Acutrack 2 screw the cutting flute of the screw not straight at the tip. To date there have been no complaint incidents or adverse events reported related to the devices. Recall start date: December 27, 2024

What you should do

  • Customer notification. Customers to return affected devices to manufacturer for replacement.
Additional official information
AudienceGeneral public
CategoryHealth products - Medical devices - Orthopaedics
CompaniesAcumed, LLC 5885 Ne Cornelius Pass Road, Hillsboro, Oregon, United States, 97124
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76880
Background{}
CompaniesAcumed, LLC 5885 Ne Cornelius Pass Road, Hillsboro, Oregon, United States, 97124
AudiencesGeneral public
Source updated2025-01-29

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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