BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutme...

FDA Device Recall #Z-0830-2017 — Class II — September 14, 2016

Recall Summary

Recall Number Z-0830-2017
Classification Class II — Moderate risk
Date Initiated September 14, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Biomet 3i, LLC
Location Palm Beach Gardens, FL
Product Type Devices
Quantity 27

Product Description

BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Reason for Recall

A limited number of product pouches may not have been sealed during packaging.

Distribution Pattern

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

Lot / Code Information

Part # ILPAC3530 Lot # 2016030311

Other Recalls from Biomet 3i, LLC

Recall # Classification Product Date
Z-0077-2021 Class II CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Refer... Aug 31, 2020
Z-0078-2021 Class II CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Ref... Aug 31, 2020
Z-0073-2021 Class II BellaTek Encode Defin3DPMSERitive Abutments-3D ... Aug 31, 2020
Z-0075-2021 Class II CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference ... Aug 31, 2020
Z-0074-2021 Class II BELLATEK TITANIUM ABUTMENT 4.1MM Reference Num... Aug 31, 2020

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

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.