# FDA recall Z-2617-2023

> **ETHICON, LLC** · Class II · device recall initiated 2023-08-10.

## Product

PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z421H-50, Z421H-50, Z421H-50, Z422H-50, Z422H-50, Z422H-50, Z422H-50, Z422H-50, Z422H-50, Z422H-50, Z423H-50, Z423H-50, Z423H-50, Z442H-50, Z442H-50, Z442H-50, Z443H-50, Z443H-50, Z443H-50, Z443H-50, Z443H-50, Z443H-50, Z443H-50, Z443H-50, Z489G-50, Z489G-50, Z489G-50, Z489G-50, Z493G-50, Z493G-50, Z493G-50, Z493G-50, Z493G-50, Z494G-50, Z495G-05, Z495G-05, Z495G-05, Z496G-50, Z496G-50, Z496G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z503G-50, Z504G-50, Z507G-50, Z507G-50, Z683G-05, Z833G-05, Z833G-05, Z844G-50

## Reason for recall

Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.

## Distribution

US Nationwide. Global Distribution.

## Key facts

- **Recall number:** Z-2617-2023
- **Recalling firm:** ETHICON, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-10
- **Report date:** 2023-09-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Guaynabo, PR, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2617-2023

## Citation

> AI Analytics. FDA recall Z-2617-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2617-2023. Source: US FDA. Licensed CC0.

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