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Open, Classified

Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental

FDA Recall Z-0152-2024 · Posted 2023-10-24

Recalling FirmPreat Corp
Recall StatusOpen, Classified
Product CodeNHA
Date Initiated2023-07-18
Product Quantity13 units

Reason for Recall

The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage

Firm Action

On August 4, 2023, Preat Corporation issued a "Urgent Medical Device Recall" notification via: USPS. Preat ask consignees to take the following actions: Product within the scope of the recall shall be discarded or returned to Preat Corporation. Instructions for the return will be provided. Complete and email response form to Nichole Fetterman, E-Mail: [email protected] or mail to Preat Corporation, Attn. Nichole Fetterman, 2625 Skyway Drive, Ste. B, Santa Maria, CA 93455

Root Cause

Process change control

Distribution Pattern

US: FL, CA, OR, TX, OH, CA, SC, OR, NJ, SC, OUS: None

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K220823Preat AbutmentsPreat Corporation · 2022-10-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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