Stradis Implant Packs
Brand(s)
Last updated
Summary
Product
Stradis Implant Packs
Issue
Medical devices - Sterility Issue
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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