Wright Medical Recalls Evolve Stem Implants Due to Sterility Assurance Issues
Wright Medical Technology is recalling 16 Evolve Stem 8.5mm implants because they lack sterility assurance. The recall covers units distributed in the US and several international countries.
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: The recall involves a lack of sterility assurance for an implantable medical device, which presents a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Wright Medical Technology Inc is recalling 16 units of the EVOLVE STEM 8.5MM (Model # 496S085) medical device. The recall is being conducted due to a lack of sterility assurance for these specific implants.
The affected product is identified by Lot # 1668777. These units were distributed to facilities in the United States, specifically in California, Colorado, Florida, Georgia, Massachusetts, Missouri, Ohio, Pennsylvania, and Texas. The product was also distributed to Australia, Canada, Chile, Israel, and Spain.
Healthcare providers and patients should contact Wright Medical Technology or their local FDA office for further instructions on how to handle the recalled devices. Patients who have received these implants should consult with their healthcare provider regarding any potential risks or necessary follow-up care.
The recalled product
- Product
- EVOLVE STEM 8.5MM Model # 496S085
- Manufacturer
- Wright Medical Technology Inc
- Affected units
- 16
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 (1)
- Lot # 1668777
Distribution
Related recalls
Same manufacturer · Wright Medical Technology Inc
See all →- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- HighStryker Infinity Resection Adjustment Block Recall: Missing Locking Screw
FDA (Devices) · 2024-04-10
- HighStryker Infinity Alignment Frame Distal Sub-Assembly Recalled for Manufacturing Defect
FDA (Devices) · 2023-07-12
- HighStryker ORTHOLOC 3Di Fusion Plate Recalled for Incorrect Marked Descriptions
FDA (Devices) · 2023-05-03
- HighStryker ORTHOLOC 3Di Fusion Plate Contains Incorrect Laser Markings
FDA (Devices) · 2023-05-03
Same hazard · infection risk
See all →- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Sterilization Monitoring Failure
FDA (Devices) · 2026-10-14
- HighFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighRecall of Medical Convenience Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
Similar recalls
- ModerateWright Medical Recalls PRO-STIM Injectable Due to Sterility Documentation Issues
FDA (Devices) · 2019-12-04
- ModerateWright Medical Recalls Valor Screws Due to Sterility Documentation Issues
FDA (Devices) · 2019-12-04
- ModerateWright Medical Recalls Swanson Trapezium Implants Due to Sterility Documentation Issues
FDA (Devices) · 2019-12-04
- ModerateWright Medical Recalls Tibial Stem Components Due to Sterility Documentation Issues
FDA (Devices) · 2019-12-04
- HighOrthopedic implant recall due to labeling mismatch on Stryker EVOLVE Proline Stem
FDA (Devices) · 2022-10-12
- ModerateWright Medical Recalls Swanson Finger Joint Implants Due to Sterility Documentation Issues
FDA (Devices) · 2019-12-04