# FDA recall Z-2544-2017

> **Medtronic** · Class II · device recall initiated 2017-05-03.

## Product

Sutures.  BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M

## Reason for recall

Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

## Distribution

Worldwide distribution.  US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.

## Key facts

- **Recall number:** Z-2544-2017
- **Recalling firm:** Medtronic
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-03
- **Report date:** 2017-06-21
- **Termination date:** 2019-07-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Haven, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2544-2017

## Citation

> AI Analytics. FDA recall Z-2544-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2544-2017. Source: US FDA. Licensed CC0.

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