Health product recall

Stradis Implant Packs

Last updated

Summary

Product
Stradis Implant Packs
Issue
Medical devices - Sterility
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Sacor Basic Implant Pack

22241489853

40310SBI

University Of Toronto Implant Pack

22229491074

41111UTI

Simcoe Dental Surgical Pack

22235489632

41236SDSP

Liang Surgical Pack

22230489371

40996WLS

Basic Implant Pack

22228490663

40561BIP

Issue

Following an internal product review, Stradis identified certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.  Use of the kits that do not maintain sterility as a result of the incomplete seal of the outer bag may result in patient risk of infection.

Recall start date: November 2, 2022

Additional information

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

Stradis Healthcare

3025 Northwoods Parkway, Peachtree Corners, Georgia, United States, 30071

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72395

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