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BIOMET 3I, LLC

Last updated May 24, 2026

Information

Country: US
Address: —
Website: biomet.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)342-5454
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 186127825

Catalogue (2523)

Page 3 of 51

Device	Model / Reference	Registries	Class	Status
Certain® Provide®	PRK654	FDA UDI	Class I	Active
Certain® Provide®	IPA5255	FDA UDI	Class II	Unknown
Osseotite® Xp®	FOS3213	FDA UDI	Class II	Unknown
Osseotite Nt®	NTDI510	EUDAMEDFDA UDI	Class I	Active
Osseotite® Xp®	FOS4507	FDA UDI	Class II	Unknown
Tapered Screw-Vent® Implant System	PSATH4	FDA UDI	Class II	Active
Osseotite® Certain® 2	XIFOSS615	FDA UDI	Class II	Active
Osseotite® Xp® Certain®	IFOS5613	FDA UDI	Class II	Unknown
Nanotite™ Certain®	NIOSM315	FDA UDI	Class II	Unknown
Immediate Molar	IMDR56SP	FDA UDI	Class I	Active
3i T3® DCD®	BNST613	FDA UDI	Class II	Active
Driva™ Gold Series Drills	SP57D51G	FDA UDI	Class I	Active
Certain® Preformance®	IMPFP354	FDA UDI	Class II	Active
Driva™ Gold Series Drills	SP44D38SG	FDA UDI	Class I	Active
Osseoguard®	TR250TCL-2	FDA UDI	Class II	Active
3i T3®	BOES311	FDA UDI	Class II	Active
Bellatek®	IF6121	FDA UDI	Class II	Active
Nanotite®	NOSM311	FDA UDI	Class II	Unknown
Gingihue®	WPP572G	FDA UDI	Class II	Active
Bellatek® Certain®	ILDEST3	FDA UDI	Class II	Active
Certain® Provide®	PAK5455	FDA UDI	Class II	Unknown
Prep-Tite®	PTC475	FDA UDI	Class II	Unknown
Nanotite®	NOSS513	FDA UDI	Class II	Unknown
Osseotite®	NT413	FDA UDI	Class II	Active
Bellatek®	IAT4	FDA UDI	Class II	Active
3i T3®	BOES565	FDA UDI	Class II	Active
TSX Implants	TSX41B13	FDA UDI	Class II	Active
Immediate Molar	IMDR88	FDA UDI	Class I	Active
Certain®	ILPAC4530	FDA UDI	Class II	Active
Navigator®	SGTT485S	FDA UDI	Class I	Active
Dríva™ Gold Series Drills	TSV51SG	FDA UDI	Class I	Active
Bellatek® Certain®	ILDEST5	FDA UDI	Class II	Active
Locator®	LOA004	FDA UDI	Class II	Active
3i T3®	BOSS315	FDA UDI	Class II	Active
Navigator® Certain®	SGIAM44	FDA UDI	Class I	Active
Ep®	WTH68	FDA UDI	Class II	Active
Navigator®	MSGTD10S	EUDAMEDFDA UDI	Class I	Active
Nanotite®	NOSM385	FDA UDI	Class II	Unknown
Bellatek®	LDAN6	FDA UDI	Class II	Active
Navigator®	SGD2B	FDA UDI	Class I	Active
Act®	ACT426SSP	EUDAMEDFDA UDI	Class I	Active
Certain®	IIIC42	FDA UDI	Class I	Active
3i T3® DCD®	BNSS318	FDA UDI	Class II	Active
Immediate Molar	IMDR51T3PSP	FDA UDI	Class I	Active
Trabecular Metal™ and TSV®	TSVKITG	FDA UDI	Class I	Active
3i T3®	BOSS413	FDA UDI	Class II	Active
Certain®	ISWHA66	FDA UDI	Class II	Active
3i T3® SHORT	BOES506	FDA UDI	Class II	Active
Quickbridge®	QBCAP	FDA UDI	Class II	Active
Driva™ Gold Series Drills	SP34G	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Aug 31, 2020	Z-0077-2021	—	terminated	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
Aug 31, 2020	Z-0076-2021	—	terminated	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
Aug 31, 2020	Z-0078-2021	—	terminated	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
Aug 31, 2020	Z-0075-2021	—	terminated	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
Aug 31, 2020	Z-0074-2021	—	terminated	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
Aug 31, 2020	Z-0073-2021	—	terminated	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
Aug 31, 2020	Z-0079-2021	—	terminated	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
Jan 10, 2020	Z-1380-2020	—	terminated	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
Jan 10, 2020	Z-1375-2020	—	terminated	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
Jan 10, 2020	Z-1383-2020	—	terminated	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
Jan 10, 2020	Z-1370-2020	—	terminated	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
Jan 10, 2020	Z-1374-2020	—	terminated	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
Jan 10, 2020	Z-1371-2020	—	terminated	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
Jan 10, 2020	Z-1366-2020	—	terminated	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
Jan 10, 2020	Z-1369-2020	—	terminated	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
Jan 10, 2020	Z-1372-2020	—	terminated	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
Jan 10, 2020	Z-1381-2020	—	terminated	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
Jan 10, 2020	Z-1386-2020	—	terminated	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
Jan 10, 2020	Z-1382-2020	—	terminated	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
Jan 10, 2020	Z-1376-2020	—	terminated	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
Jan 10, 2020	Z-1368-2020	—	terminated	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
Jan 10, 2020	Z-1387-2020	—	terminated	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
Jan 10, 2020	Z-1367-2020	—	terminated	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
Jan 10, 2020	Z-1379-2020	—	terminated	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
Jan 10, 2020	Z-1388-2020	—	terminated	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
Jan 10, 2020	Z-1377-2020	—	terminated	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
Jan 10, 2020	Z-1384-2020	—	terminated	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
Jan 10, 2020	Z-1385-2020	—	terminated	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
Jan 10, 2020	Z-1378-2020	—	terminated	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
Jan 10, 2020	Z-1373-2020	—	terminated	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
Feb 26, 2019	Z-2143-2019	—	terminated	During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Feb 26, 2019	Z-2142-2019	—	terminated	During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Feb 26, 2019	Z-2141-2019	—	terminated	During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Feb 26, 2019	Z-2144-2019	—	terminated	During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Feb 26, 2019	Z-2140-2019	—	terminated	During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Mar 8, 2017	Z-1701-2017	—	terminated	A single lot of product that potentially has a single part within the lot that does not match the product on the label due to a commingle at the firm supplier
Sep 14, 2016	Z-0835-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0831-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0860-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0849-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0841-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0836-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0846-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0861-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0848-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0854-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0857-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0862-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0847-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0838-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0842-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0830-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0844-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0845-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0856-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0855-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0851-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0852-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0850-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0829-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0853-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0834-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0859-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0833-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0840-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0828-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0843-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0837-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0863-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0839-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0832-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0858-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Aug 8, 2016	Z-2845-2016	—	terminated	Product was incorrectly packaged.
Nov 25, 2015	Z-2481-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2410-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2466-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2454-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2522-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2471-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2461-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2415-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2487-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2449-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2465-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2445-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2420-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2470-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2456-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2463-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2479-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2477-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2423-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2427-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2434-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2516-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2519-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2441-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2417-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2408-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2426-2016	—	terminated	Pouches may not have been sealed during packing.