BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], ...
FDA Device Recall #Z-0812-2022 — Class II — February 14, 2022
Recall Summary
| Recall Number | Z-0812-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 14, 2022 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Biomet, Inc. |
| Location | Warsaw, IN |
| Product Type | Devices |
| Quantity | 2594 |
Product Description
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 Pattern
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
Lot / Code Information
44 lots: Lot #, UDI # - [014490, (01)00887868447037(17)310608(10)014490], [014500, (01)00887868447068(17)310608(10)014500], [014520, (01)00887868447068(17)310610(10)014520], [084850, (01)00887868447006(17)310621(10)084850], [084860, (01)00887868447006(17)310623(10)084860], [084870, (01)00887868447006(17)310623(10)084870], [084880, (01)00887868447006(17)310624(10)084880], [102920, (01)00887868447006(17)310630(10)102920], [102930, (01)00887868447006(17)310716(10)102930], [102940, (01)00887868447006(17)310729(10)102940], [102950, (01)00887868447006(17)310729(10)102950], [102960, (01)00887868447006(17)310728(10)102960], [103120, (01)00887868447006(17)310728(10)103120], [119750, (01)00887868446054(17)310624(10)119750], [119760, (01)00887868446054(17)310624(10)119760], [120800, (01)00887868446054(17)310630(10)120800], [120810, (01)00887868446054(17)310713(10)120810], [204700, (01)00887868447006(17)310714(10)204700], [205750, (01)00887868447006(17)310714(10)205750], [331580, (01)00887868446054(17)310803(10)331580], [331590, (01)00887868446054(17)310723(10)331590], [331600, (01)00887868446054(17)310726(10)331600], [386440, (01)00887868447105(17)310809(10)386440], [391450, (01)00887868446054(17)310816(10)391450], [391470, (01)00887868447068(17)310811(10)391470], [391660, (01)00887868447068(17)310811(10)391660], [391670, (01)00887868447075(17)310811(10)391670], [416500, (01)00887868446054(17)310817(10)416500], [416510, (01)00887868446054(17)310817(10)416510], [416520, (01)00887868446054(17)310819(10)416520], [416640, (01)00887868446054(17)310823(10)416640], [492660, (01)00887868447006(17)310722(10)492660], [534680, (01)00887868446948(17)310713(10)534680], [534690, (01)00887868446948(17)310713(10)534690], [534700, (01)00887868446948(17)310812(10)534700], [610840, (01)00887868446948(17)310915(10)610840], [806490, (01)00887868447075(17)310528(10)806490], [820340, (01)00887868447006(17)310618(10)820340], [834950, (01)00887868446733(17)311101(10)834950], [836360, (01)00887868446948(17)310119(10)836360], [896640, (01)00887868446733(17)311101(10)896640], [896660, (01)00887868446733(17)311027(10)896660], [939270, (01)00887868447068(17)310601(10)939270], [964360, (01)00887868447068(17)310603(10)964360]
Other Recalls from Biomet, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0212-2026 | Class II | BIOMET ZipTight, Acute AC Joint Implant, Single... | Sep 23, 2025 |
| Z-2619-2025 | Class II | Juggerknot Mini Soft Anchors, Model/Catalog Num... | Sep 9, 2025 |
| Z-0477-2025 | Class II | JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model nu... | Oct 21, 2024 |
| Z-2179-2024 | Class II | RingLoc Bi-Polar Hip System Acetabular Cup, 41 ... | May 17, 2024 |
| Z-1607-2024 | Class II | Vanguard Knee System AS Tibial Bearing / DCM Ar... | Mar 13, 2024 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.