Wright EVOLVE TRIAD Plate Cutter fails sterilization requirements under double-wrap configuration
Wright Medical recalls 231 EVOLVE TRIAD Plate Cutters due to sterilization failure when double-wrapped. The devices cannot be adequately sterilized, creating infection risk during surgical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a surgical device with a documented functional defect preventing proper sterilization under specified conditions, creating direct risk of surgical site infections during invasive procedures. Although no illnesses or injuries have been reported, the device qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High severity rating per the rubric.
Plain-English summary
Wright Medical Technology, Inc. is recalling 231 units of the Wright EVOLVE TRIAD Plate Cutter (Reference 49510120) distributed in the United States, Puerto Rico, Australia, Canada, Chile, Colombia, and Hong Kong. The recall was issued because the device is unable to meet sterilization requirements when sterilized in a double-wrapped configuration using the Option 1 Steam Sterilization parameters detailed in the instructions for use.
The EVOLVE TRIAD Plate Cutter is a surgical instrument used in orthopedic procedures. When inadequately sterilized due to this design limitation, it creates risk of surgical site infections and other serious complications during use.
The affected lots are: 955401, 1168853, 1349302, 1956936, and 2486857. Healthcare facilities currently using these devices should verify their inventory against these lot numbers.
If you have received affected units, do not use them with double-wrapped sterilization according to Option 1 Steam Sterilization parameters. Contact Wright Medical Technology, Inc. for guidance on alternative sterilization methods or return of the devices. Affected lots should be quarantined or removed from surgical inventory.
The recalled product
- Product
- Wright EVOLVE TRIAD Plate Cutter, REF 49510120
- Manufacturer
- Wright Medical Technology, Inc.
- Affected units
- 231
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot codes: 955401
- 1168853
- 1349302
- 1956936
- 2486857
Distribution
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