Recall MonitorHealth Products
Mixing Bowl And Spatula, 20- Pack
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Orthopaedics
Product: Mixing Bowl And Spatula, 20- Pack
Issue: Medical devices - Sterility
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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.