Health product recall

Mixing Bowl And Spatula, 20- Pack

Brand(s)
Last updated

Summary

Product
Mixing Bowl And Spatula, 20- Pack
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 catalogue number

Mixing Bowl And Spatula, 20- Pack

85390028

00-5049-011-00

Mixing Bowl And Spatula, 20- Pack

82395238

00-5049-011-00

Mixing Bowl And Spatula, 20- Pack

85390022

00-5049-011-00

Mixing Bowl And Spatula, 20- Pack

85390024

00-5049-011-00

Issue

Zimmer Biomet is conducting a lot specific medical device recall removal for the mixing bowl and spatula. Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Seal integrity testing conducted internally showed potential sterility breach in 7.5% of the tested units that had visual seal nonconformities. The devices are distributed in 20-pack boxes.

The defectiveness was discovered on November 19, 2025. Issue was identified through the complaints handling process.

 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Orthopaedics
Companies
Zimmer Inc.
1800 West Center Street, Warsaw, Indiana, United States, 46580
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81888

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