Home / Recalls / Biomet 3i, LLC / Z-1377-2020

Z-1377-2020 Class II Terminated

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

FDA device recall Z-1377-2020 was initiated by Biomet 3i, LLC on January 10, 2020 and is designated Class II. Reason for recall: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment The recall status is terminated (terminated August 2, 2021). Affected quantity: N/A.

Recall Details

Product Type
Devices
Report Date
March 4, 2020
Initiation Date
January 10, 2020
Termination Date
August 2, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA456

Reason for Recall

Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment

Distribution Pattern

Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK

Code Information

Lot Numbers: 1229560

Other recalls by Biomet 3i, LLC

  • Z-0078-2021 Class II — CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5 (August 31, 2020)
  • Z-0074-2021 Class II — BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4 (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-0079-2021 Class II — CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6 (August 31, 2020)
  • Z-0076-2021 Class II — CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5 (August 31, 2020)
  • Z-0075-2021 Class II — CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4 (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-1376-2020 Class II — CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Referenc (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)

FDA data resources