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High RiskFDAfda-Z-0019-2020OTHER

Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

Units Affected
167
Recall Date
May 30, 2019
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0019-2020.

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.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0019-2020.

Recall terminated by FDA.

✅ What you should do

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. Contact Paltop Advanced Dental Solutions Ltd or the retailer where you bought it for a refund, replacement, or repair.
  4. For the most current official instructions, visit the FDA recall page.
  5. If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0019-2020.

Paltop Advanced Dental Solutions Ltd

FDA

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Paltop Advanced Dental Solutions Ltd Recall FAQ

Paltop Advanced Dental Solutions Ltd is the subject of a medical implants safety report: Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P. The notice was published on May 30, 2019 by the U.S. Food and Drug Administration (FDA). Approximately 167 units are potentially affected.