Home / Recalls / Biomet 3i, LLC / Z-0075-2021

Z-0075-2021 Class II Terminated

Recalled by Biomet 3i, LLC — Palm Beach Gardens, FL

Recall Details

Product Type
Devices
Report Date
October 14, 2020
Initiation Date
August 31, 2020
Termination Date
July 6, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9 units

Product Description

CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4

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 Pattern

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

Code Information

Lot Numbers: 8563336-1 8563892-1 8563910-1 8565718-2 8571887-1 8571887-2 8571887-3 8572668-1 8572668-2 UDI: (01)00844868031147(10)8563336-1 (01)00844868031147(10)8563892-1 (01)00844868031147(10)8563910-1 (01)00844868031147(10)8565718-2 (01)00844868031147(10)8571887-1 (01)00844868031147(10)8571887-2 (01)00844868031147(10)8571887-3 (01)00844868031147(10)8572668-1 (01)00844868031147(10)8572668-2

Other recalls by Biomet 3i, LLC

  • Z-0078-2021 Class II — CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5 (August 31, 2020)
  • Z-0079-2021 Class II — CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6 (August 31, 2020)
  • Z-0077-2021 Class II — CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4 (August 31, 2020)
  • Z-0073-2021 Class II — BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: (August 31, 2020)
  • Z-0076-2021 Class II — CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5 (August 31, 2020)
  • Z-0074-2021 Class II — BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4 (August 31, 2020)
  • Z-1384-2020 Class II — CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Reference N (January 10, 2020)
  • Z-1382-2020 Class II — CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Reference (January 10, 2020)
  • Z-1388-2020 Class II — CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference Nu (January 10, 2020)
  • Z-1381-2020 Class II — CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Referenc (January 10, 2020)