R3 Acetabular System - 0 Hole Acetabular Shell, 3 Hole Acetabular Shell, 0 Hole Ha Coated Acetabular Shell, 3 Hole Ha Coated Acetabular Shell, Multi-hole Acetabular Shell (2020-04-23)
Recall Summary Zimmer Biomet is recalling several models of R3 Acetabular System components (hip replacement shells) distributed across Canada because they may not meet sterility standards. The affected products include 0-hole, 3-hole, and multi-hole acetabular shells, with and without HA coating. This is a Class I recall, meaning there is a reasonable possibility that use of the product will cause serious adverse health consequences or death.
- Reason
- Medical devices
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2020-05-15
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/134abf1d-508e-4872-8fc9-dab2805c57d4