---
title: "STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in ... — FDA record Z-0150-2023 | Is It on Recall"
description: "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"
url: https://isitonrecall.com/recall/fda-device-z-0150-2023-stratafix-spiral-pga-pcl-uni-ud-20cm-usp2-0-m3-s-a-sh-indicated-for-use-in-soft-tissue-approximation/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use ... — FDA record Z-0150-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 20, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: 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
- **Classification**: Class II
- **Recalling firm**: Ethicon, Inc.
- **Quantity**: 2,280 eaches
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0150-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0150-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI-DI: 10705031228061 Lot/Serial No.: B903HPU Expiry Date: 08/21/2026 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

International distribution of the country of China.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Nov 9, 2022
- **Recall initiation date**: Sep 20, 2022
- **Center classification date**: Oct 31, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0150-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Ethicon, Inc. records](https://isitonrecall.com/brand/ethicon-inc/)