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Open, Classified

Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software Version: N/A

FDA Recall Z-1313-2025 · Posted 2025-03-11

Recalling FirmTruAbutment Inc.
Recall StatusOpen, Classified
Product CodeNDP
Date Initiated2023-12-27
Product Quantity61 units

Reason for Recall

Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately

Firm Action

On 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.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

US: CA, CO, FL, GA, IA, IL, MD, MN, MS, OH, OR, SD, UT, VA, WA, WI OUS: Japan, Great Britain , Canada

Official Source

View FDA Recall →

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

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