# FDA recall Z-2616-2023

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

## Product

PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP507V05, PDP510V05, PDP515V05, PDP662H50, PDP663H50, PDP684H40, PDP9615H40, PDP9625H40, PDP9626H40, PDP9631H40, PDP9715H15, PDP9715H40, PDP9733H16, PDP9861H40, PDP9865H40, XWPDP421H40, XWPDP423H40, XWPDP442H40, XWPDP443H16

## 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-2616-2023
- **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-2616-2023

## Citation

> AI Analytics. FDA recall Z-2616-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-2616-2023. Source: US FDA. Licensed CC0.

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