Z-1061-2019Class II

Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications...

Name: Z-1061-2019 Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications...
Creator: Keystone Dental Inc
Published: 2019-02-22
License: https://open.fda.gov/license/

Keystone Dental Inc. / initiated 2019-02-22 / Terminated / root cause: manufacturing process

FDA source

Keystone Dental Inc began a recall of Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part... on 2019-02-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1061-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-22
Posted: 2019-03-27
Terminated: 2020-06-19
Recalling firm: Keystone Dental Inc.
Product: Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 60-70112
Product code: DZE Implant, Endosseous, Root-Form
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Keystone Dental initiated recall by phone to each one of the impacted customers. The phone call was then followed by a Recall Notification Letter that was mailed via overnight FedEx mail on February 22, 2019. Letters states problem and action to take: Replacement 1.25mm Hex Driver(s) have been provided to you with this letter. The 1.25mm Hex Driver(s) currently in your kit should be discarded. Please refer to the images on page 2 to locate the driver within your kit. This issue is limited to this 1.25mm Hex Driver(s) only and no other product within the kit is affected by this issue. Complete the Reply Communication form.
Quantity in commerce: 13 kits hex Driver
Distribution: FL, MA, SC, VA
Product codes and lots: Lot Numbers: WO-010252, WO-010136

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1061-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1061-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-27
Z-1062-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-27
Z-1063-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-27
Z-1064-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-27

Product code DZE

K112795Class IIPaltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd. / cleared 2012-04-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)