CLASS II Device recall · Reported 30 Sep 2020 · FDA Enforcement Report
Evolve Stem recalled by Wright Medical Technology
Wright Medical Technology is recalling Evolve Stem, distributed in 9 states. The recall was initiated on 26 Aug 2020 and the FDA has classified it as Class II.
Check your package
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-2989-2020
- FDA event ID
- 86278
- Recalling firm
- Wright Medical Technology, Arlington, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Aug 2020
- FDA classified
- 21 Sep 2020
- Reported
- 30 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 26 Aug 2020 | Recall initiated by company | |
| 21 Sep 2020 | Classified by FDA | +26 days |
| 30 Sep 2020 | 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
Lack of sterility assurance
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
EVOLVE STEM 8.5MM Model # 496S085
Where it was distributed
USA states: CA, CO, FL, GA, MA, MO, OH, PA, TX OUS: Australia, Canada, Chile, Israel, Spain
CaliforniaColoradoFloridaGeorgiaMassachusettsMissouriOhioPennsylvaniaTexas
Questions about this recall
Why was it recalled?
Lack of sterility assurance
Which lots are affected?
Lot # 1668777
Where was it sold?
USA states: CA, CO, FL, GA, MA, MO, OH, PA, TX OUS: Australia, Canada, Chile, Israel, Spain
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 26 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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