Public recall detail

Stradis Implant Packs

2022-12-21

medium
Recall Safety notice
Quick summary

Quick summary: Stradis Implant Packs. Date: 2022-12-21.

Recommended action

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

Recall details

Quick summary: Stradis Implant Packs. Date: 2022-12-21.

Official details

Affected product details

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

BrandStradis Healthcare
ProductStradis Implant Packs
IssueMedical devices - Sterility
Recall classType II
IdentificationRA-72395

Affected products

ProductSacor Basic Implant Pack
Lot22241489853
Model40310SBI
Serial number22241489853
DescriptionSacor Basic Implant Pack
ProductUniversity Of Toronto Implant Pack
Lot22229491074
Model41111UTI
Serial number22229491074
DescriptionUniversity Of Toronto Implant Pack
ProductSimcoe Dental Surgical Pack
Lot22235489632
Model41236SDSP
Serial number22235489632
DescriptionSimcoe Dental Surgical Pack
ProductLiang Surgical Pack
Lot22230489371
Model40996WLS
Serial number22230489371
DescriptionLiang Surgical Pack
ProductBasic Implant Pack
Lot22228490663
Model40561BIP
Serial number22228490663
DescriptionBasic Implant Pack

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General and plastic surgery
CompaniesStradis Healthcare 3025 Northwoods Parkway, Peachtree Corners, Georgia, United States, 30071
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-72395
Background{}
CompaniesStradis Healthcare 3025 Northwoods Parkway, Peachtree Corners, Georgia, United States, 30071
AudiencesHealthcare
Source updated2022-12-21

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

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