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.
What this means for you
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
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