---
title: "STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product cod... — FDA record Z-1053-2022 | Is It on Recall"
description: "Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up."
url: https://isitonrecall.com/recall/fda-device-z-1053-2022-stratafix-spiral-pga-pcl-uni-ud-sizes-20cm-usp2-0-m3-s-a-rb-1-product-code-sxmd1b403-12-and-30cm-usp/
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 sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/... — FDA record Z-1053-2022

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 Mar 24, 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 sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].
- **Reason**: Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
- **Classification**: Class II
- **Recalling firm**: Ethicon, Inc.
- **Quantity**: 2808 (all OUS)
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1053-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1053-2022%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 | Lot AAHM529, UDI(01)10705031228054(20)12(17)260331(10)AAHM529 Lot AAHQ049, UDI (01)10705031228047(20)12(17)260430(10)AAHQ049 |

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

## Distribution

International distribution in the country of China.

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

## Dates in the source

- **Report date**: May 18, 2022
- **Recall initiation date**: Mar 24, 2022
- **Center classification date**: May 10, 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-1053-2022%22)

## Related records

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