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U.S. Department of Health and Human Services

Class 2 Device Recall CN38SB

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 Class 2 Device Recall CN38SBsee related information
Date Initiated by FirmDecember 27, 2023
Date PostedMarch 11, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1313-2025
Recall Event ID 96246
Product Classification Accessories, implant, dental, endosseous - Product Code NDP
ProductBrand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software Version: N/A
Code Information Lot Code: KCCBB1216110/ UDI: (01)08800076411791
Recalling Firm/
Manufacturer		 TruAbutment Inc.
17666 Fitch
Irvine CA 92614-6022
For Additional Information ContactCustomer Support
1-714-9561488
Manufacturer Reason
for Recall		Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionOn February 3, 2025, TruAbutment Inc. begin to reach out to affected customers about the recall. On February 13, 2025, TruAbutment Inc. followed up with consignees by phone and followed up the phone call with a "Urgent: Medical Device Recall" Notification. TruAbutment asked consignees to take the following actions: 1. Stop usage and quarantine all CN38-SB until your on-hand products are verified. 2. Check all unopened CN38-SB. a. Please check the Lot # and quarantine the products with Lot # KCCBB1216110. 3. Then check the opened CN38-SB products. 4. Please quarantine any unaligned products. 4. Please return the quarantined products back to TruAbutment with the signed acknowledgement and replacement form that is attached to this letter. 5.If the product was transferred or distributed to a different facility, please forward this notification and inform TruAbutment Inc. by contacting the customer support team with the information below.
Quantity in Commerce61 units
DistributionUS: CA, CO, FL, GA, IA, IL, MD, MN, MS, OH, OR, SD, UT, VA, WA, WI OUS: Japan, Great Britain , Canada
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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