Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artif...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1061-2019.
Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1061-2019.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Keystone Dental Inc or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- 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-1061-2019.
Keystone Dental Inc
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Keystone Dental Inc Recall FAQ
Keystone Dental Inc is the subject of a medical implants safety report: Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artif.... The notice was published on February 22, 2019 by the U.S. Food and Drug Administration (FDA). Approximately 13 units are potentially affected.