# FDA recall Z-0812-2022

> **Biomet, Inc.** · Class II · device recall initiated 2022-02-14.

## Product

BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X160MM CALIBRATED DRILL], [ALPS Drill Bit, Item # 824273100, 4.5X150MM DRILL], [ALPS Drill Bit, Item # 829029170, 2.5X140MM DRILL], [ALPS Drill Bit, Item # 829032170, 3.5X140MM DRILL], [ALPS Tap, Item # 824150170, 3.5X140MM CORTICAL TAP], [ALPS Guide Pin, Item # 829516150, 1.6X150MM BAYONET TIP GUIDE PIN], [ALPS Guide Pin, Item # 829516151, 1.6X150MM THREADED TIP GUIDE PIN]. Instruments 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 for recall

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.

## 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

## Key facts

- **Recall number:** Z-0812-2022
- **Recalling firm:** Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-02-14
- **Report date:** 2022-03-30
- **Termination date:** 2024-09-30

- **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-0812-2022

## Citation

> AI Analytics. FDA recall Z-0812-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0812-2022. Source: US FDA. Licensed CC0.

---

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