# FDA recall Z-0882-2021

> **Biomet, Inc.** · Class II · device recall initiated 2020-12-23.

## Product

A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, osteotomies and non-unions of the clavicle including osteopenic bone.

## Reason for recall

The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increased chance of fracture of the drill.

## Distribution

Nationwide distribution.

## Key facts

- **Recall number:** Z-0882-2021
- **Recalling firm:** Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-23
- **Report date:** 2021-01-27
- **Termination date:** 2023-04-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0882-2021

## Citation

> AI Analytics. FDA recall Z-0882-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0882-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*