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Open, Classified

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

FDA Recall Z-1321-2024 · Posted 2024-03-20

Recalling FirmPreat Corp
Recall StatusOpen, Classified
Product CodeNHA
Date Initiated2024-02-09
Product Quantity561 units

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.

Firm Action

On 02/09/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via US certified mail to customers to inform them that the abutment was manufactured with a dimensional condition that may lead to reduced engagement between the prosthetic screw and the implant. Customer are instructed to inspect their inventory and discard or return the affected products to PREAT CORPORATION. For questions or further assistance contact the Quality Assurance Manager at 800-232-7732 or email at [email protected] On 2/16/2024, the firm sent via certified USPS mail an "URGENT: MEDICAL DEVICE RECALL UPDATE" which informs customer to notify all personnel within their company, and of their customers where the affected products may have been further distributed of the recall.

Root Cause

Process change control

Distribution Pattern

U.S. Nationwide distribution in the states of AZ, OH and PA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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