Official recall record
Acrobat-i Stabilizer Z and Acrobat-i Positioner Z
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-10-31
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
The contract manufacturer of the Acrobat product family reported deviations in the manufacturing process that creates the sterile barrier. Specifically, in some instances, the tray sealing step was performed multiple times using the same package, which is outside of the validated process. Although testing suggests that product is sterile immediately after being sealed with this non-validated process, we cannot ensure that the product will remain sterile for the duration of its 2-year shelf life. Recall Start Date: October 21, 2024
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.