Recall Z-1313-2025 ยท NDP Accessories, Implant, Dental, Endosseous
TruAbutment Inc.
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
| Date | Mar 11, 2025 (initiated Dec 27, 2023) |
| Status | Open, Classified |
| Reason | Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately |
| Root cause | Unknown/Undetermined by 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 prod |
| Quantity | 61 units |
| Distribution | US: CA, CO, FL, GA, IA, IL, MD, MN, MS, OH, OR, SD, UT, VA, WA, WI OUS: Japan, Great Britain , Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.