---
title: "BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 85620400... — FDA record Z-0811-2022 | Is It on Recall"
description: "Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infectio"
url: https://isitonrecall.com/recall/fda-device-z-0811-2022-biomet-trauma-a-l-p-s-fibula-composite-locking-plate-8-hole-item-856204008-devices-are-packaged-in-a/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum seal... — FDA record Z-0811-2022

Reported terminated

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 Feb 14, 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**: BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.
- **Reason**: Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
- **Classification**: Class II
- **Recalling firm**: Biomet, Inc.
- **Quantity**: 12
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-0811-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0811-2022%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 # 913430, UDI:(01)00887868445897(17)310616(10)913430 |

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

## Distribution

Worldwide: US (28 States AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MS, NC, NE, NM, NY, OH, OK, OR, SC, TX, UT, WA, WY), Australia, Japan, and Netherlands

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

- [Alabama](https://isitonrecall.com/state/alabama/)
- [Arizona](https://isitonrecall.com/state/arizona/)
- [California](https://isitonrecall.com/state/california/)
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- [Connecticut](https://isitonrecall.com/state/connecticut/)
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- [Kansas](https://isitonrecall.com/state/kansas/)
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- [Maryland](https://isitonrecall.com/state/maryland/)
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- [Mississippi](https://isitonrecall.com/state/mississippi/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [Nebraska](https://isitonrecall.com/state/nebraska/)
- [New Mexico](https://isitonrecall.com/state/new-mexico/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Oklahoma](https://isitonrecall.com/state/oklahoma/)
- [Oregon](https://isitonrecall.com/state/oregon/)
- [South Carolina](https://isitonrecall.com/state/south-carolina/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Utah](https://isitonrecall.com/state/utah/)
- [Washington](https://isitonrecall.com/state/washington/)
- [Wyoming](https://isitonrecall.com/state/wyoming/)

## Dates in the source

- **Report date**: Mar 30, 2022
- **Recall initiation date**: Feb 14, 2022
- **Center classification date**: Mar 18, 2022
- **Termination date**: Sep 30, 2024

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-0811-2022%22)

## Related records

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