Biomet 3i, LLC: Medical Device Recall in 2020 - (Recall #: Z-0078-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5

Product Classification:

Class II

Date Initiated: August 31, 2020

Date Posted: October 14, 2020

Recall Number: Z-0078-2021

Event ID: 86402

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

Status: Terminated

Product Quantity: 10 units

Code Information:

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

Distribution Pattern:

FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA

Voluntary or Mandated:

Voluntary: Firm initiated