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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