Scan Abutment PCA recall
Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital…
Why was Scan Abutment PCA recalled?
Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay the final restoration.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots manufactured prior to July 21, 2021.
- Product
- Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital…
- Recalling firm
- Paltop Advanced Dental Solutions Ltd
- Quantity
- 68
- Distribution
- US Nationwide distribution. No foreign distribution from US.
- Recall date
- October 13, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)