Paltop Advanced Plus Dental Implant Recall for Surface Topography Defects
Paltop Advanced Dental Solutions is recalling 167 dental implants because surface micro/nano topography may be inconsistent. The recall covers units distributed to 16 states.
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 medical device with a defect that may affect performance (inconsistent surface topography), which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Paltop Advanced Dental Solutions Ltd is recalling 167 units of the Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm (Catalog Number: 20-70024P). The recall was initiated because the surface micro/nano topography on some of the implants contained within this lot may not be consistently present over the entire surface of the implant.
The affected lot is identified by Lot Number W0-008254 and UDI 729010869611020-70024P. The source text does not specify the exact distribution dates or the specific facilities receiving the product, but notes that the units were distributed to Alabama, Arizona, California, Colorado, Florida, Georgia, Massachusetts, Maryland, Missouri, Montana, New Jersey, New Mexico, New York, Ohio, South Carolina, and Virginia.
Consumers and healthcare providers who have purchased or received these specific dental implants should contact Paltop Advanced Dental Solutions Ltd for further instructions on how to return or replace the product. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
- Manufacturer
- Paltop Advanced Dental Solutions Ltd
- Category
- Medical Device — Dental Implants
- Affected units
- 167
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 Number: W0-008254 UDI: 729010869611020-70024P
Distribution
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