BIOMET TRAUMA Drill Bit — Class II medical device recall Z-0812-2022
Terminated recall by Biomet, Inc., reported 2022-03-30, distributed in AL, AZ, CA, CO, CT, FL, GA, ID…. Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrie
| Recall number | Z-0812-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2022-02-14 |
| Classified | 2022-03-18 |
| Reported by FDA | 2022-03-30 |
| Terminated | 2024-09-30 |
| Distributed | 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 |
| Countries outside the US | AU, JP, NL |
| Quantity | 2,594 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00887868446054, 00887868446733, 00887868446948, 00887868447006, 00887868447037, 00887868447068, 00887868447075, 00887868447105 |
| Model numbers | 1.6X150MM, 2.2MM, 2.5X140MM, 2.7X160MM, 212000022, 214227160, 3.5X140MM, 4.5X150MM, 824150170, 824273100, 829029170, 829032170, 829516150, 829516151 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0812-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.