CLASS II Device recall · Reported 3 Apr 2019 · FDA Enforcement Report

Paltop 25 Hex Drivers, Short recalled by Keystone Dental

Keystone Dental is recalling Paltop 25 Hex Drivers, Short, distributed in Florida, Massachusetts, South Carolina, Virginia. The recall was initiated on 22 Feb 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: WO-010354

Quantity recalled3 Hex Driver

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1064-2019
FDA event ID: 82374
Recalling firm: Keystone Dental, Burlington, MA
Classification: Class II
Status: Terminated
Recall initiated: 22 Feb 2019
FDA classified: 27 Mar 2019
Reported: 3 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

22 Feb 2019	Recall initiated by company
27 Mar 2019	Classified by FDA	+33 days
3 Apr 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Paltop 1.25 Hex Drivers, Short Part Number: 60-70102

Where it was distributed

FL, MA, SC, VA

Florida Massachusetts South Carolina Virginia

Questions about this recall

Is Paltop 25 Hex Drivers, Short recalled?

Yes. Keystone Dental recalled Paltop 25 Hex Drivers, Short on 22 Feb 2019. The recall is Class II and its status is Terminated. Recall number Z-1064-2019.

Why was it recalled?

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

Which lots are affected?

Lot Number: WO-010354

Where was it sold?

FL, MA, SC, VA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Keystone Dental

All 16

Reported	Class	Recall	Company	Reason	Where
3 Apr 2019Device	CLASS II	Paltop 25 Hex Drivers, Long recalled by Keystone Dental	Keystone Dental	Other	4 states
3 Apr 2019Device	CLASS II	Paltop Fully Guided Surgical Kit recalled by Keystone Dental	Keystone Dental	Other	4 states
3 Apr 2019Device	CLASS II	Paltop Premium Surgical Kit-containing the Hex Driver recalled	Keystone Dental	Other	4 states
20 Jun 2018Device	CLASS II	Prima Plus ¿4.1 Implant recalled by Keystone Dental	Keystone Dental	Labeling Errors	14 states
2 May 2018Device	CLASS II	Genesis Surgical Cassette Tapered Implants are intended recalled	Keystone Dental	Other	Nationwide

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