# FDA recall Z-2376-2018

> **Implant Direct Sybron Manufacturing, LLC** · Class II · device recall initiated 2018-05-18.

## Product

REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60

## Reason for recall

Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant

## Distribution

CA, FL, GA, IL, LA, MI, MT, NC, NJ, NY, OK, OR, SC, SD, TN & WA; International: Jordan, Great Britain, Germany, Spain, Italy & Poland

## Key facts

- **Recall number:** Z-2376-2018
- **Recalling firm:** Implant Direct Sybron Manufacturing, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-18
- **Report date:** 2018-07-11
- **Termination date:** 2020-07-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Thousand Oaks, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2376-2018

## Citation

> AI Analytics. FDA recall Z-2376-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-2376-2018. Source: US FDA. Licensed CC0.

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