CLASS II ONGOING Device recall · Reported 20 Jul 2022 · FDA Enforcement Report

Wright Evolve Triad Plate Cutter recalled by Wright Medical Technology

Wright Medical Technology is recalling Wright Evolve Triad Plate Cutter, distributed nationwide in the US. The recall was initiated on 14 Jun 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot codes: 955401, 1168853, 1349302, 1956936, 2486857

Quantity recalled231

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1366-2022
FDA event ID: 90399
Recalling firm: Wright Medical Technology, Memphis, TN
Classification: Class II
Status: Ongoing
Recall initiated: 14 Jun 2022
FDA classified: 11 Jul 2022
Reported: 20 Jul 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

14 Jun 2022	Recall initiated by company
11 Jul 2022	Classified by FDA	+27 days
20 Jul 2022	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Wright EVOLVE TRIAD Plate Cutter, REF 49510120

Where it was distributed

Nationwide and PR, and Australia, Canada, Chile, Colombia, Hong Kong, Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Is Wright Evolve Triad Plate Cutter recalled?

Yes. Wright Medical Technology recalled Wright Evolve Triad Plate Cutter on 14 Jun 2022. The recall is Class II and its status is Ongoing. Recall number Z-1366-2022.

Why was it recalled?

Which lots are affected?

Lot codes: 955401, 1168853, 1349302, 1956936, 2486857

Where was it sold?

Nationwide and PR, and Australia, Canada, Chile, Colombia, Hong Kong, Puerto Rico

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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