CanadaMixing Bowl And Spatula, 20‑pack by Zimmer Inc. (model/catalogue 00-5049-011-00; lot numbers 85390028, 82395238, 85390022, 85390024) are affected. They were recalled because package seals showed incomplete seals, wrinkles or peeling and internal testing showed potential sterility breach in 7.5% of tested units; contact the manufacturer for more information.
What's being recalled
Companies: Zimmer Inc., 1800 West Center Street, Warsaw, Indiana, United States, 46580.
How to identify it
Affected products: Mixing Bowl And Spatula, 20- Pack; Lot or serial number: 85390028; Model or catalogue number: 00-5049-011-00
Affected products: Mixing Bowl And Spatula, 20- Pack; Lot or serial number: 82395238; Model or catalogue number: 00-5049-011-00
Affected products: Mixing Bowl And Spatula, 20- Pack; Lot or serial number: 85390022; Model or catalogue number: 00-5049-011-00
Affected products: Mixing Bowl And Spatula, 20- Pack; Lot or serial number: 85390024; Model or catalogue number: 00-5049-011-00
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)