medical Class II Updated 2020-10-14

Biomet 3i, LLC recalls CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number:

Recalled Product

CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4

Hazard / Issue

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

Issued by

FDA

Affected States: FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA
Lot/Code Info: Lot Numbers: 8560281-1 8560299-1 8561332-3 8561476-1 8563315-1 8564057-1 8564060-3 8564060-4 8564064-1 8564524-1 8564524-2 8565357-1 8565414-3 8566637-1 8566637-2 8566648-1 8566969-2 8567559-1 8567578-1 8568041-1 8568705-1 8568819-1 8569841-7 8569987-1 8570625-1 8570737-1 8571824-1 8571843-1 8571850-1 8571866-1 8571887-4 8571887-5 8572228-1 8572238-1 8572238-2 UDI: (01)00844868031185(10)8560281-1 (01)00844868031185(10)8560299-1 (01)00844868031185(10)8561332-3 (01)00844868031185(10)8561476-1 (01)00844868031185(10)8563315-1 (01)00844868031185(10)8564057-1 (01)00844868031185(10)8564060-3 (01)00844868031185(10)8564060-4 (01)00844868031185(10)8564064-1 (01)00844868031185(10)8564524-1 (01)00844868031185(10)8564524-2 (01)00844868031185(10)8565357-1 (01)00844868031185(10)8565414-3 (01)00844868031185(10)8566637-1 (01)00844868031185(10)8566637-2 (01)00844868031185(10)8566648-1 (01)00844868031185(10)8566969-2 (01)00844868031185(10)8567559-1 (01)00844868031185(10)8567578-1 (01)00844868031185(10)8568041-1 (01)00844868031185(10)8568705-1 (01)00844868031185(10)8568819-1 (01)00844868031185(10)8569841-7 (01)00844868031185(10)8569987-1 (01)00844868031185(10)8570625-1 (01)00844868031185(10)8570737-1 (01)00844868031185(10)8571824-1 (01)00844868031185(10)8571843-1 (01)00844868031185(10)8571850-1 (01)00844868031185(10)8571866-1 (01)00844868031185(10)8571887-4 (01)00844868031185(10)8571887-5 (01)00844868031185(10)8572228-1 (01)00844868031185(10)8572238-1 01)00844868031185(10)8572238-2
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →

Related medical Recalls

Boston Scientific Corporation recalls Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Cathete

2022-08-31 · The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.

Mckesson Medical-Surgical Inc. Corporate Office recalls MEDLINE INDUSTRIES Medline Plug, Catheter Medline Plastic, w

2022-08-31 · Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

GE Healthcare, LLC recalls (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (

2022-08-31 · Inaccurate Distance and Area measurements with use of Global Stack viewport.

Mckesson Medical-Surgical Inc. Corporate Office recalls B. BRAUN MEDICAL INC. Anesthesia Support Tray SUPPORT TRAY,

2022-08-31 · Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.