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U.S. Department of Health and Human Services

Class 2 Device Recall Nobel Active/Conical RP Titanium Blank

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  Class 2 Device Recall Nobel Active/Conical RP Titanium Blank see related information
Date Initiated by Firm February 09, 2024
Date Posted March 20, 2024
Recall Status1 Open3, Classified
Recall Number Z-1321-2024
Recall Event ID 94032
510(K)Number K183518  
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
Product Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
Code Information Model Number: 9000967 UDI-DI code: 00842092165867 Lot Numbers: 235650, 234294, 233667, 233885, 233439, and 231489
Recalling Firm/
Manufacturer		 Preat Corp
2625 Skyway Dr Ste B
Santa Maria CA 93455-1405
For Additional Information Contact Nichole Fetterman
800-232-7732
Manufacturer 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.
FDA Determined
Cause 2		 Process change control
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 nfetterman@younginnovations.com 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.
Quantity in Commerce 561 units
Distribution U.S. Nationwide distribution in the states of AZ, OH and PA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = NHA and Original Applicant = Preat Corporation
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