Biomet 3i, LLC

Complete recall history across all FDA and CPSC categories — 222 total recalls

Biomet 3i, LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (222)

FDA medical device enforcement actions by Biomet 3i, LLC. Showing most recent 50.

Date Product Reason Class
Aug 31, 2020 CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5 Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees ... Class II
Aug 31, 2020 CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6 Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees ... Class II
Aug 31, 2020 BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbe... Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees ... Class II
Aug 31, 2020 CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4 Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees ... Class II
Aug 31, 2020 CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4 Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees ... Class II
Aug 31, 2020 CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5 Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees ... Class II
Aug 31, 2020 BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4 Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees ... Class II
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 6MM(H) Refe... Resulting impression or scanned data produced from the Healing Abutment lots ... Class II
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Refere... Resulting impression or scanned data produced from the Healing Abutment lots ... Class II
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H) Refere... Resulting impression or scanned data produced from the Healing Abutment lots ... Class II
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) ... Resulting impression or scanned data produced from the Healing Abutment lots ... Class II
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference... Resulting impression or scanned data produced from the Healing Abutment lots ... Class II
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) Referen... Resulting impression or scanned data produced from the Healing Abutment lots ... Class II
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H) Referen... Resulting impression or scanned data produced from the Healing Abutment lots ... Class II
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Refer... Resulting impression or scanned data produced from the Healing Abutment lots ... Class II
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H) Referen... Resulting impression or scanned data produced from the Healing Abutment lots ... Class II
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Referen... Resulting impression or scanned data produced from the Healing Abutment lots ... Class II
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Refe... Resulting impression or scanned data produced from the Healing Abutment lots ... Class II
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Referen... Resulting impression or scanned data produced from the Healing Abutment lots ... Class II
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H) Refere... Resulting impression or scanned data produced from the Healing Abutment lots ... Class II
Jan 10, 2020 CERTAIN¿ BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H) Ref... Resulting impression or scanned data produced from the Healing Abutment lots ... Class II
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Referenc... Resulting impression or scanned data produced from the Healing Abutment lots ... Class II
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) ... Resulting impression or scanned data produced from the Healing Abutment lots ... Class II
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Refere... Resulting impression or scanned data produced from the Healing Abutment lots ... Class II
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Refer... Resulting impression or scanned data produced from the Healing Abutment lots ... Class II
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Refere... Resulting impression or scanned data produced from the Healing Abutment lots ... Class II
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Referen... Resulting impression or scanned data produced from the Healing Abutment lots ... Class II
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) Refe... Resulting impression or scanned data produced from the Healing Abutment lots ... Class II
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Referen... Resulting impression or scanned data produced from the Healing Abutment lots ... Class II
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Referenc... Resulting impression or scanned data produced from the Healing Abutment lots ... Class II
Feb 26, 2019 CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - Product ... During manufacturing, the screw stop ledge was not made to specification and ... Class II
Feb 26, 2019 CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage... During manufacturing, the screw stop ledge was not made to specification and ... Class II
Feb 26, 2019 CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product ... During manufacturing, the screw stop ledge was not made to specification and ... Class II
Feb 26, 2019 CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product ... During manufacturing, the screw stop ledge was not made to specification and ... Class II
Feb 26, 2019 CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage... During manufacturing, the screw stop ledge was not made to specification and ... Class II
Mar 8, 2017 BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within ... A single lot of product that potentially has a single part within the lot tha... Class II
Sep 14, 2016 BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE An endosseous dental implant abut... A limited number of product pouches may not have been sealed during packaging. Class II
Sep 14, 2016 BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER An endosseous ... A limited number of product pouches may not have been sealed during packaging. Class II
Sep 14, 2016 BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 3MM(H) An endosseous dental im... A limited number of product pouches may not have been sealed during packaging. Class II
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous denta... A limited number of product pouches may not have been sealed during packaging. Class II
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H) An endosseous d... A limited number of product pouches may not have been sealed during packaging. Class II
Sep 14, 2016 BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) TRANSFER IMPRESSION COPING An e... A limited number of product pouches may not have been sealed during packaging. Class II
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H) An endosseous d... A limited number of product pouches may not have been sealed during packaging. Class II
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endoss... A limited number of product pouches may not have been sealed during packaging. Class II
Sep 14, 2016 BIOMET 3i LOW PROFILE ABUTMENT HEXED TEMPORARY CYLINDER An endosseous dent... A limited number of product pouches may not have been sealed during packaging. Class II
Sep 14, 2016 BIOMET 3i LOW PROFILE ABUTMENT HEALING CAP An endosseous dental implant abut... A limited number of product pouches may not have been sealed during packaging. Class II
Sep 14, 2016 BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental im... A limited number of product pouches may not have been sealed during packaging. Class II
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 4MM(H) An endoss... A limited number of product pouches may not have been sealed during packaging. Class II
Sep 14, 2016 BIOMET 3i LOW PROFILE ABUTMENT (HEXED) PICK-UP IMPRESSION COPING An endosseo... A limited number of product pouches may not have been sealed during packaging. Class II
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 5MM(H) An endosseous d... A limited number of product pouches may not have been sealed during packaging. Class II

View all 222 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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