Lower riskMedical device recall · FDA · Published August 26, 2020
Wright Medical EVOLVE STEM 8.5MM Model 496S085 Recall: Lack of Sterility Assurance
Wright Medical recalls EVOLVE STEM 8.5MM Model 49:496S085 due to lack of sterility assurance. Affected units may pose infection risks during medical procedures.
“Wright Medical EVOLVE STEM 8.5MM Model 496S085 Recall: Lack of Sterility Assurance.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64425-wright-medical-evolve-stem-8-5mm-model-496s085-recall-lack. Based on FDA recall #Z-2989-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2989-2020%22&limit=1).
Wright Medical Technology Inc recalled EVOLVE STEM 8.5MM Model # 496S085 due to a lack of sterility assurance, the FDA said on Aug. 26, 2020. The voluntary Class II recall affects 16 stems distributed in the U.S. and several other countries.
How to tell if you have it
Brand: Wright Medical
Product: EVOLVE STEM 8.5MM
Model #: 496S085
Lot #: 1668777
The hazard
The recall cites a lack of sterility assurance for the EVOLVE STEM 8.5MM device, according to the FDA.
Context
GovInfoNow's records show Wright Medical Technology, Inc. has 20 other recalls on record since March 14, 2018. Other recent recalls of similar products include Charlotte Claw Screw Recall (Aug. 18, 2026), Stryker Infinity Resection Adjustment Block Recall (March 6, 2024), and Stryker Infinity Alignment Frame Distal Sub-Assembly Recall (June 13, 2023). Additional similar product recalls include Medline Convenience Kits Recall: Calibration Issues May Impact Sterility (Jan. 7, 2026) and Medline Surgical Packs Recall: Calibration Issues May Impact Sterility (Jan. 7, 2026).
How to tell if you have this one
Check for the model number 496S085 on the device packaging or label. The product was sold with lot number 1668777.
Brand
Wright Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Sterility
Ensure the device is properly sterilized before use if it is part of the recalled model.
Where it went and when
Where it was distributed
Distributed in 9 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “USA states: CA, CO, FL, GA, MA, MO, OH, PA, TX OUS: Australia, Canada, Chile, Israel, Spain” States read from FDA’s own wording; “not listed” means the notice does not name it.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2989-2020 (August 26, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2989-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.