Implant Direct Scan Adapter Assembly Replant platform for the… — Class II medical device recall Z-0261-2020
Terminated recall by Implant Direct Sybron Manufacturing, LLC, reported 2019-11-06, distributed in CA, CO, FL, GA, LA, MA, NE, NJ…. The action is being initiated due to incorrect assembly of the scan adapter . The result of the incorrect asse
| Recall number | Z-0261-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Implant Direct Sybron Manufacturing, LLC, Westlake Village, CA, United States |
| Recall initiated | 2018-09-06 |
| Classified | 2019-10-31 |
| Reported by FDA | 2019-11-06 |
| Terminated | 2021-07-01 |
| Distributed | CA, CO, FL, GA, LA, MA, NE, NJ, NY, OH, PA, SC, UT, VA |
| Countries outside the US | AU, CA |
| Quantity | 107 scan |
| UPC / GTIN / UDI-DI | 10841307123934, 10841307123941, 10841307123958 |
| Lot numbers | 104511, 104539, 104540, 6035-09PT, 6043-09PT, 6050-09PT |
| Model numbers | 6035-09PT-M |
Product
Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)/UDI : 10841307123941; and 6050-09PT-M (5.00mmD)/ UDI: 10841307123958
Reason for recall
The action is being initiated due to incorrect assembly of the scan adapter . The result of the incorrect assembly could cause the clinician not to be able to capture the position and orientation of a dental implant(s) or lab analog during the digital scanning process which could result in a delay for the patient.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0261-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.