Quick summary
Quick summary: Tandem INTL Bipolar 46OD 28ID . Date: 2024-10-30.
Public recall detail
Tandem INTL Bipolar 46OD 28ID
2024-10-30
Recall
Safety notice
Recommended action
Recommended action: compare your product with the official notice and follow the instructions published by the official source.
Recall details
Quick summary: Tandem INTL Bipolar 46OD 28ID . Date: 2024-10-30.
Official details
Affected product details
Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.
BrandSmith & Nephew, Inc.
ProductTandem INTL Bipolar 46OD 28ID
IssueMedical devices - Performance
Recall classType II
IdentificationRA-76411
Affected products
ProductTandem INTL Bipolar 46OD 28ID
LotW2401399
Model71324046
Serial numberW2401399
DescriptionTandem INTL Bipolar 46OD 28ID
Issue
Smith & Nephew, Inc., has initiated a field action to voluntarily remove a batch of Tandem Bipolar 46OD 28ID due to the assembly of an oversized retainer ring in the product. This results in a reduced retention force of the bipolar assembly. Recall Start Date: October 15, 2024
What you should do
- Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Orthopaedics
CompaniesSmith & Nephew, Inc. 1450 Brooks Road, Memphis, Tennessee, United States, 38116
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76411
Background{}
CompaniesSmith & Nephew, Inc. 1450 Brooks Road, Memphis, Tennessee, United States, 38116
AudiencesHealthcare
Source updated2024-10-30
Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.
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