Recall Z-1061-2019— Keystone Dental Inc

Name: FDA recall Z-1061-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-22

Class II · Terminated

Class II FDA medical device recall by Keystone Dental Inc, initiated 2019-02-22, terminated 2020-06-19. It names one FDA 510(k) clearance: K112795. 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. Reason: 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.

Recalling firm: Keystone Dental Inc
Classification: Class II
Status: Terminated
Initiated: 2019-02-22
Terminated: 2020-06-19
Firm location: Burlington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K112795 — PALTOP DENTAL IMPLANT SYSTEMPaltop Advanced Dental Solutions, Ltd.·cleared 2012-04-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.