# FDA recall Z-0261-2020

> **Implant Direct Sybron Manufacturing, LLC** · Class II · device recall initiated 2018-09-06.

## 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.

## Distribution

US: OH, CO, UT, NY, PA, CA, FL , GA, LA, NE, NJ,SC, MA, VA, UT,   OUS: Canada, Australia,

## Key facts

- **Recall number:** Z-0261-2020
- **Recalling firm:** Implant Direct Sybron Manufacturing, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-06
- **Report date:** 2019-11-06
- **Termination date:** 2021-07-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Westlake Village, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0261-2020

## Citation

> AI Analytics. FDA recall Z-0261-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0261-2020. Source: US FDA. Licensed CC0.

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