# FDA recall Z-1041-2020

> **Implant Direct Sybron Manufacturing LLC** · Class II · device recall initiated 2019-10-07.

## Product

Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213

## Reason for recall

Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.

## Distribution

U.S. Nationwide distribution in the states of:  KS, LA, OH, RI, CA, NJ, MA, FL, UT, ID, MO, WY, WI, PA, WA.    O.U.S. (Foreign): DE, IT, HU, JP

## Key facts

- **Recall number:** Z-1041-2020
- **Recalling firm:** Implant Direct Sybron Manufacturing LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-07
- **Report date:** 2020-02-12
- **Termination date:** 2021-04-28

- **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-1041-2020

## Citation

> AI Analytics. FDA recall Z-1041-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1041-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*