Biomet 3i, LLC: CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5

Is my product affected?

CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5

• UPC 00844868031192

Check against the official notice below — it lists the full affected range.

What happened

Biomet 3i, LLC is recalling certain BellaTek Titanium Abutment 5.0mm Encode Definitive Abutments because the hex component was misaligned by 30 degrees during manufacturing compared to the patient scan data provided. This misalignment means the abutment will not seat properly in the correct orientation when a dentist attempts to place it with the patient. A total of 10 units across ten lot numbers have been distributed in Florida, Georgia, Idaho, Illinois, Michigan, Nevada, New York, Ohio, South Carolina, Tennessee, and Virginia.

The recall affects units from lot numbers 8561074-1, 8563880-1, 8564060-1, 8565449-1, 8565945-1, 8566616-1, 8568052-1, 8568808-1, 8569206-1, and 8571880-1. The source record does not specify what remedy or action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient

Details from the source

Reason for recall: Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient Distribution: FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA Quantity: 10 units Lot/code info: Lot Numbers: 8561074-1 8563880-1 8564060-1 8565449-1 8565945-1 8566616-1 8568052-1 8568808-1 8569206-1 8571880-1 UDI: (01)00844868031192(10)8561074-1 (01)00844868031192(10)8563880-1 (01)00844868031192(10)8564060-1 (01)00844868031192(10)8565449-1 (01)00844868031192(10)8565945-1 (01)00844868031192(10)8566616-1 (01)00844868031192(10)8568052-1 (01)00844868031192(10)8568808-1 (01)00844868031192(10)8569206-1 (01)00844868031192(10)8571880-1

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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