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U.S. Department of Health and Human Services

Class 2 Device Recall Various

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 Class 2 Device Recall Varioussee related information
Date Initiated by FirmJune 25, 2024
Date PostedAugust 19, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2687-2024
Recall Event ID 94933
Product Classification Accessories, implant, dental, endosseous - Product Code NDP
ProductMultiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303 3i Certain-compatible 5.0mm Digital Analog, REF 9001903 3i Certain-compatible 6.0mm Digital Analog, REF 9002003 Astra-compatible 3.0mm Digital Analog, REF 9002103 Astra-compatible Aqua 3.5/4.0mm Digital Analog, REF 9002203 Astra-compatible Lilac 4.5/5.0mm Digital Analog, REF 9002203 BioHorizons-compatible 3.0mm Digital Analog, REF 9005203 Legacy-compatible 3.0mm Digital Analog, REF 9005303 Digital Analog - BioHorizons - 3.5mm, Digital Analog - BioHorizons - 4.5mnm, REF 9005403 Legacy-compatible 3.5mm Digital Analog, REF 9005503 Legacy-compatible 5.7mm Digital Analog, REF 9008503 Astra EV 4.8mm Milled Titanium Abutment REF 9006767 Digital analogs are used for visual inspection of abutments and restoration in the dental laboratory.
Code Information Model Numbers: 9000703, 9001303, 9001903, 9002003, 9002103, 9002203, 9002203, 9005203, 9005203, 9005303, 9005403, 9005503, 9008503, 9006767 UDI-DI codes: 00842092178690, 00842092181898, 00842092181959, 00842092178737, 00842092178775, 00842092178812, 00842092178812, 00842092178898, 00842092178898, 00842092178997, 00842092178928, 00842092178959, 00842092182130 Lot Numbers: 250219, 248890, 251432, 250602, 250418, 250213, 251459, 249071, 250335, 250223, 250336, 249510, 250215.
FEI Number 2918719
Recalling Firm/
Manufacturer		 Preat Corp
2625 Skyway Dr Ste B
Santa Maria CA 93455-1405
For Additional Information ContactJose Espino
224-622-7191
Manufacturer Reason
for Recall		Due to a manufacturing issue, the product has a out of specification rotation of the digital analog used to visually inspect dental abutments and restorations.
FDA Determined
Cause 2		Process control
ActionOn 07/22/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL UPDATE" Letter via certified mail informing customers that Digital Analogs were manufactured out of specification for the rotational feature which may result in the dental restoration/implant may be slightly different than the position of the actual implant in the patient's mouth. Customers are instructed to: Product in the scope of this recall should be discarded or returned to PREAT CORPORATION. For questions contact Quality Regulatory Affairs at 224-622-7191 or email jespino@younginnovations.com
Quantity in Commerce185 devices
DistributionU.S. Nationwide distribution in the states of AK, AZ, FL, GA, IL, LA, MD, MI, MN, NY, OH, OK, OR, PA, RI, TX, UT, and WA
Total Product Life CycleTPLC 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.
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