# FDA recall Z-0150-2023

> **Ethicon, Inc.** · Class II · device recall initiated 2022-09-20.

## Product

STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.  Product No.: SXMD1B405-12

## Reason for recall

Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair

## Distribution

International distribution of the country of China.

## Key facts

- **Recall number:** Z-0150-2023
- **Recalling firm:** Ethicon, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-20
- **Report date:** 2022-11-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Somerville, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0150-2023

## Citation

> AI Analytics. FDA recall Z-0150-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0150-2023. Source: US FDA. Licensed CC0.

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