# FDA recall Z-1126-2020

> **Implant Direct Sybron Manufacturing LLC** · Class II · device recall initiated 2019-01-09.

## Product

SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708

## Reason for recall

Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect  color coded vials and caps. The part/lot numbers were correct, the customer received the product they ordered, however the color on the vial label and cap labels were incorrect.Specifically, the color coded vial and cap does not match the implant size described on the vial. As a result of the incorrect color on the vial and cap, the surgeon may not be certain if the implant received was the correct size. This could result in a delay in surgery, risk of infection if the surgical site has to be closed up and a second round of anesthesia.

## Distribution

US: None  OUS: Iceland, Sweden, Spain,

## Key facts

- **Recall number:** Z-1126-2020
- **Recalling firm:** Implant Direct Sybron Manufacturing LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-09
- **Report date:** 2020-02-19
- **Termination date:** 2021-04-27

- **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-1126-2020

## Citation

> AI Analytics. FDA recall Z-1126-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1126-2020. Source: US FDA. Licensed CC0.

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