Keystone Dental Inc: Medical Device Recall in 2019 - (Recall #: Z-1061-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: February 22, 2019

Date Posted: April 3, 2019

Recall Number: Z-1061-2019

Event ID: 82374

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

Status: Terminated

Product Quantity: 13 kits hex Driver

Code Information:

Lot Numbers: WO-010252, WO-010136

Distribution Pattern:

FL, MA, SC, VA

Voluntary or Mandated:

Voluntary: Firm initiated