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
- Company
- Truabutment Inc.
- Recall Initiated
- December 27, 2023
- Posted
- March 11, 2025
- Recall Number
- Z-1313-2025
- Quantity
- 61 units
- Firm Location
- Irvine, CA
Reason for Recall
Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately
Distribution
US: CA, CO, FL, GA, IA, IL, MD, MN, MS, OH, OR, SD, UT, VA, WA, WI OUS: Japan, Great Britain , Canada
Lot / Code Info
Lot Code: KCCBB1216110/ UDI: (01)08800076411791
Root Cause
Unknown/Undetermined by firm
Action Taken
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.