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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Biomet 3i, LLC: A limited number of product pouches may not have been sealed during packaging.

Agency Publication Date: December 20, 2016
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Affected Products

Product: BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # ILPAC3217 Lot # 2015111777

Lot Numbers:
2015111777
Product: BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # ILPAC3417 Lot # 2015111355

Lot Numbers:
2015111355
Product: BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # ILPAC3530 Lot # 2016030311

Lot Numbers:
2016030311
Product: BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # ILPAC4217 Lot # 2015112156, 2015112157, 2015112158, 2015112159, 2015120466, 2016010159, 2016031210, 2016040438, and 2016061525

Lot Numbers:
2015112156
Product: BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # ILPAC4330 Lot # 2015111372, 201611713, 2016020101, and 2016050131

Lot Numbers:
2015111372
Product: BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # ILPAC4417 Lot # 2016011141, 2016020088, and 2016031214

Lot Numbers:
2016011141
Product: BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # ILPAC4530 Lot # 2015111373, 2015111778, 201520886, 2015120887, and 2016021477

Lot Numbers:
2015111373
Product: BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # ILPC342 Lot # 2015121064 and 2016030816

Lot Numbers:
2015121064
Product: BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # ILPC342U Lot # 2016020057,

Lot Numbers:
2016020057
Product: BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # ILPC344U Lot # 2016011182 and 2016041553

Lot Numbers:
2016011182
Product: BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # ILPC441 Lot # 2016021500

Lot Numbers:
2016021500
Product: BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # ILPC441U Lot # 2015112073, 2016040049, 2016040914, and 2016042048

Lot Numbers:
2015112073
Product: BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # ILPC442 Lot # 2016030811

Lot Numbers:
2016030811
Product: BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # ILPC442U Lot # 2015110458, 2015111460, 2015121066, 2016020509, and 2016042047

Lot Numbers:
2015110458
Product: BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # ILPC443U Lot # 2015120624

Lot Numbers:
2015120624
Product: BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # ILPC444U Lot # 201602051 and 2016040048

Lot Numbers:
201602051
Product: BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # LPAC3330 Lot # 2015120640

Lot Numbers:
2015120640
Product: BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # LPAC3530 Lot # 2015110514

Lot Numbers:
2015110514
Product: BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # LPAC4217 Lot # 2015110506, 2016030834, 2016042066, 2016042068

Lot Numbers:
2015110506
Product: BIOMET 3i LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # LPAC4330 Lot #'s 2016010803 and 2016030830

Product: BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # LPAC4417 Lot #'s 2015110513, 2016010805 and 2016050344

Product: BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # LPC441 Lot # 2015110365

Lot Numbers:
2015110365
Product: BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # LPC441U Lot # 2015120620

Lot Numbers:
2015120620
Product: BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # LPC442U Lot # 2015101819

Lot Numbers:
2015101819
Product: BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # LPC443 Lot # 201611726

Lot Numbers:
201611726
Product: BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # LPC443U Lot # 2015120622

Lot Numbers:
2015120622
Product: BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # LPC444U Lot # 2016030294

Lot Numbers:
2016030294
Product: BIOMET 3i LOW PROFILE ABUTMENT HEALING CAP An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # LPCHC Lot # 2016030791, 2016030792, 2016030793, and 2016060693

Lot Numbers:
2016030791
Product: BIOMET 3i LOW PROFILE ABUTMENT (HEXED) PICK-UP IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # LPCPIC1 Lot # 2015110454

Lot Numbers:
2015110454
Product: BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) PICK-UP IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # LPCPIC2 Lot #'s 2015112084, 2016011162, 2016011163, 2016031299, 2016041629 and 2016042021

Product: BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part #LPCPTC2 Lot #'s 2016011174, 2016011175 and 2016011178

Product: BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # LPCQB Lot # 2016040022

Lot Numbers:
2016040022
Product: BIOMET 3i LOW PROFILE ABUTMENT HEXED TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # LPCTC1 Lot # 2016030247

Lot Numbers:
2016030247
Product: BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # LPCTC2 Lot's # 2015111121, 2015120492, 2015120495, 2015120497, 2015121108, 2015121114, 2015121115, 2016011524, 2016031197, 2016031875, 2016031878, 2016050008, 2016060232, 2016060233, 2016060234, and 2016062347

Product: BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) TRANSFER IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # LPCTIC2 Lots # 2015110366, 2015110389, 2015110450, 2015110451, 2015110452, 2016021488, 2016021489, 2016021490, and 2016040888

Product: BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Part # LPCTSH Lots # 2016021930, 2016022074, 2016031247, 2016031248, 2016040024, 2016040025, 2016040064, 2016040898, 2016041632, 2016041635, 2016042030, and 2016042036

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 75761
Status: Resolved
Manufacturer: Biomet 3i, LLC
Manufactured In: United States
Units Affected: 36 products (127; 53; 27; 735; 431; 150; 228; 50; 101; 64; 123; 450; 108; 525; 46; 108; 20; 4; 246; 175; 216; 160; 204; 137; 50; 191; 124; 391; 28; 458; 270; 60; 108; 1,371; 191; 1,633)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.