Wright EVOLVE TRIAD Plate Cutter, REF 49510120
Reported: July 20, 2022 Initiated: June 14, 2022 #Z-1366-2022
Product Description
Wright EVOLVE TRIAD Plate Cutter, REF 49510120
Reason for Recall
The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam Sterilization parameters detailed in instructions for use
Details
- Recalling Firm
- Wright Medical Technology, Inc.
- Units Affected
- 231
- Distribution
- Nationwide and PR, and Australia, Canada, Chile, Colombia, Hong Kong, Puerto Rico
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
Wright EVOLVE TRIAD Plate Cutter, REF 49510120. Recalled by Wright Medical Technology, Inc.. Units affected: 231.
Why was this product recalled? ▼
The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam Sterilization parameters detailed in instructions for use
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 20, 2022. Severity: Moderate. Recall number: Z-1366-2022.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11