---
title: "BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener. — FDA record Z-0957-2026 | Is It on Recall"
description: "Removal of affected lot of screws due to labeling error."
url: https://isitonrecall.com/recall/fda-device-z-0957-2026-biosure-ha-screw-6mm-x-20-mm-threaded-metallic-bone-fixation-fastener/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener. — FDA record Z-0957-2026

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 Nov 24, 2025. 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**: BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
- **Reason**: Removal of affected lot of screws due to labeling error.
- **Classification**: Class II
- **Recalling firm**: Smith & Nephew, Inc.
- **Quantity**: 168 units (US 83; OUS 85)
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0957-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0957-2026%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 | Model No. 72201768, 72204389; UDI: 03596010611642, 00885554036572; Batch No. 51315219, 51306803. |

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

## Distribution

US (nationwide) distribution to states of : AL, CA, CO, FL, IA, IL, KY, MN, NC, NE, NY, OK, TN, TX, UT; OUS (Foreign) to countries of: Australia, Czech Republic, Finland, France, Germany, Indonesia, Italy, Malaysia, Martinique, Mexico, Netherlands, Norway, Poland, Singapore, Switzerland.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

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## Dates in the source

- **Report date**: Dec 24, 2025
- **Recall initiation date**: Nov 24, 2025
- **Center classification date**: Dec 18, 2025

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-0957-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Smith & Nephew, Inc. records](https://isitonrecall.com/brand/smith-nephew-inc/)