Recall Z-1321-2024— Preat Corp

Name: FDA recall Z-1321-2024
Creator: U.S. Food and Drug Administration
Published: 2024-02-09

Class II · Ongoing

Class II FDA medical device recall by Preat Corp, initiated 2024-02-09. It names one FDA 510(k) clearance: K183518. Product: Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967. Reason: Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant..

Recalling firm: Preat Corp
Classification: Class II
Status: Ongoing
Initiated: 2024-02-09
Firm location: Santa Maria, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K183518 — Preat AbutmentsPreat Corporation·cleared 2019-03-18

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

Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967

Reason for recall

Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant.

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