Data / Medical devices / United States / ZimVie US Corp LLC
ZimVie US Corp LLC: FDA-registered device maker in Palm Beach Gardens, FL, United States, 101 510(k) clearances
ZimVie US Corp LLC is registered with the FDA (registration 1038806) in Palm Beach Gardens, FL, United States. It lists 9 device types. The FDA files 101 510(k) clearances under its listings, the newest dated October 23, 2024. 60 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1038806
- Address
- 4555 Riverside Drive, Palm Beach Gardens, FL, United States, 33410
- Owner or operator
- ZimVie US Corp LLC (1038806)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- December 29, 1993
- Registered through
- 2026
- Brand names listed
- 3i T3 Ex Hex Parallel Walled Implant, 3i T3 Ex Hex Tapered Implant, 3i T3 Non-Platform Switched Parallel Walled Implant, 3i T3 Non-Platform Switched Tapered Implant, 3i T3 Parallel Walled Implant, 3i T3 Short External Hex Parallel Walled Implant, 3i T3 Short External Hex Parallel Walled Implant with DCD, 3i T3 Tapered Implant and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Attachment, Precision, All | EGG | 1 | Specification developer | accessdata.fda.gov |
| Bone Grafting Material, Human Source | NUN | 2 | Specification developer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Manufacturer for export | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Complaint file establishment | accessdata.fda.gov |
| Template | HWT | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 101.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 23, 2024 | K241753 | Immediate Molar Implants | DZE | Substantially Equivalent | Biomet 3i, LLC | accessdata.fda.gov |
| September 14, 2022 | K220978 | TSX Implants | DZE | Substantially Equivalent | Biomet 3i, LLC | accessdata.fda.gov |
| March 28, 2022 | K213672 | T3 Pro Implants | DZE | Substantially Equivalent | Biomet 3i, LLC | accessdata.fda.gov |
| December 21, 2021 | K212730 | BellaTek Encode Emergence Healing Abutments | NHA | Substantially Equivalent | Biomet 3i, LLC | accessdata.fda.gov |
| December 9, 2019 | K192522 | TSV BellaTek Express and BellaTek Flex Abutments | NHA | Substantially Equivalent | Biomet 3i, LLC | accessdata.fda.gov |
| July 2, 2019 | K183138 | Certain BellaTek Express and BellaTek Flex Abutments | NHA | Substantially Equivalent | Biomet 3i | accessdata.fda.gov |
| December 13, 2017 | K173374 | TSV BellaTek Encode Healing Abutments | NHA | Substantially Equivalent | Biomet 3i | accessdata.fda.gov |
| November 20, 2015 | K150571 | 3i T3 Short Implants | DZE | Substantially Equivalent | Biomet 3i | accessdata.fda.gov |
| June 25, 2015 | K143505 | Zimmer Patient-Specific Abutment, Internal Hex, Titanium | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| May 1, 2015 | K143528 | Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| January 21, 2015 | K142572 | Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| October 28, 2014 | K142082 | ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| June 16, 2014 | K140570 | CHAIRSIDE ATTACHMENT PROCESSING MATERIAL | EBI | Substantially Equivalent | Zest Anchors, LLC | accessdata.fda.gov |
| March 4, 2014 | K133339 | ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATED | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| January 8, 2014 | K133049 | 3I T3(R) EXTERNAL HEX DENTAL IMPLANTS | DZE | Substantially Equivalent | Biomet 3i | accessdata.fda.gov |
| November 19, 2013 | K132258 | ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| July 30, 2013 | K130949 | CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS | DZE | Substantially Equivalent | Biomet 3i | accessdata.fda.gov |
| January 30, 2013 | K122300 | T3 DENTAL IMPLANT | DZE | Substantially Equivalent | Biomet 3i | accessdata.fda.gov |
| November 8, 2012 | K120873 | ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| September 11, 2012 | K120776 | ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION | NHA | Substantially Equivalent | Biomet 3i | accessdata.fda.gov |
| August 30, 2012 | K113753 | ZIMMER DENTAL TAPERED SCREW-VENT X | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| January 23, 2012 | K113092 | ZIMMER CONTOUR PROVISIONAL COPING | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| January 20, 2012 | K113645 | REGENEROSS ALLOGRAFT PLUS MINERLIZED | NUN | Substantially Equivalent | Biomet Interpore Cross | accessdata.fda.gov |
| January 13, 2012 | K112730 | ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION | NHA | Substantially Equivalent | Biomet 3i | accessdata.fda.gov |
| December 14, 2011 | K112160 | TAPERED SCREW-VENT X IMPLANT | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| December 8, 2011 | K111853 | ANGLED TAPERED ABUTMENT | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| December 6, 2011 | K111889 | ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| November 18, 2011 | K111216 | OSSEOTITE 2 DENTAL IMPLANTS | DZE | Substantially Equivalent | Biomet 3i, Inc. | accessdata.fda.gov |
| September 1, 2011 | K110565 | ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE | NHA | Substantially Equivalent | Biomet 3i, Inc. | accessdata.fda.gov |
| August 11, 2011 | K111852 | ANODIZED HEALING COLLAR | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| April 1, 2011 | K100724 | OSSEOTITE II MODEL XIFOSSXXX | DZE | Substantially Equivalent | Biomet 3i, Inc. | accessdata.fda.gov |
| March 11, 2011 | K101608 | BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS | NHA | Substantially Equivalent | Biomet 3i, Inc. | accessdata.fda.gov |
| March 11, 2011 | K101607 | BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMENTS | NHA | Substantially Equivalent | Biomet 3i, Inc. | accessdata.fda.gov |
| December 3, 2010 | K102209 | ENCODE PATIENT SPECIFIC ABUTMENT | NHA | Substantially Equivalent | Biomet 3i, Inc. | accessdata.fda.gov |
| November 8, 2010 | K101582 | CAM STRUCTSURE BARS | NHA | Substantially Equivalent | Biomet 3i, Inc. | accessdata.fda.gov |
| October 1, 2010 | K101880 | TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| September 14, 2010 | K101977 | TAPERED SCREW-VENT T IMPLANT | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| December 15, 2009 | K093164 | 3.25 SPLINE TWIST IMPLANT, HA COATED | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| November 30, 2009 | K092341 | LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION | NHA | Substantially Equivalent | Biomet 3i, Inc. | accessdata.fda.gov |
| November 3, 2009 | K092377 | PLASTIC TEMPORARY ABUTMENTS, MODELS: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| October 30, 2009 | K092403 | TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620 | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| April 7, 2009 | K090723 | HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5, | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| December 23, 2008 | K083474 | ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| December 19, 2008 | K082639 | ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| September 25, 2008 | K080164 | ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| July 21, 2008 | K080864 | CAM STRUCTSURE PRECISION MILLED BARS | NHA | Substantially Equivalent | Biomet 3i, Inc. | accessdata.fda.gov |
| December 20, 2007 | K072642 | BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS | NHA | Substantially Equivalent | Biomet 3i, Inc. | accessdata.fda.gov |
| October 4, 2007 | K072589 | TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16 | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| September 20, 2007 | K071439 | ZIMMER PATIENT-SPECIFIC ABUTMENT, INTERNAL HEX, TITANIUM | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| August 30, 2007 | K071551 | QUICKBRIDGE TM CYLINDER AND CAP | NHA | Substantially Equivalent | Biomet 3i, Inc. | accessdata.fda.gov |
| May 30, 2007 | K071235 | ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13 | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| May 14, 2007 | K070147 | INTERGRO ORAL | NUN | Substantially Equivalent | Biomet 3i | accessdata.fda.gov |
| April 30, 2007 | K063341 | 3I OSSEOTITE CERTAIN DENTAL IMPLANTS | DZE | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| April 24, 2007 | K063286 | OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE | DZE | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| March 20, 2007 | K063403 | CONICAL ANGLED ABUTMENT | NHA | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| February 23, 2007 | K061629 | CERTAIN PREVAIL DENTAL IMPLANT | DZE | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| October 12, 2006 | K061847 | ZIMMER CONTOUR CERAMIC ABUTMENT, MODELS ZRA341S, ZRA342S, KRA451S, ZRA452S | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| September 8, 2006 | K061410 | SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| July 21, 2006 | K061969 | PREFORMANCE POSTS AND TEMPORARY CYLINDERS | NHA | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| May 17, 2006 | K060880 | ZIMMER DENTAL ONE PIECE TAPERED ABUTMENT, MODELS TAC1, TACW1, TA5C1 | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| February 27, 2006 | K060291 | PREFORMANCE TEMPORARY CYLINDER | NHA | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| February 1, 2006 | K053170 | PREFORMANCE POSTS | NHA | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| January 23, 2006 | K052997 | ZIMMER DENTAL ONE-PIECE IMPLANT | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| October 20, 2005 | K052648 | MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS | NHA | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| October 13, 2005 | K052600 | ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED) | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| September 15, 2005 | K051461 | 3I OSSEOTITE DENTAL IMPLANTS | DZE | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| November 13, 2002 | K014050 | HEX-LOCK TEMPORARY ABUTMENT | DZE | Substantially Equivalent | Sulzer Dental, Inc. | accessdata.fda.gov |
| September 19, 2002 | K022113 | 3I DENTAL IMPLANT ACCESSORIES | DZE | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| January 18, 2002 | K013494 | 3.75MM AND 5.0MM SPLINE TWIST IMPLANT | DZE | Substantially Equivalent | Sulzer Dental, Inc. | accessdata.fda.gov |
| November 19, 2001 | K013227 | SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT | DZE | Substantially Equivalent | Sulzer Dental, Inc. | accessdata.fda.gov |
| September 28, 2001 | K012911 | 3I LOCATER ABUTMENT SYSTEM | DZE | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| June 25, 2001 | K011245 | ADVENT IMPLANT SYSTEM, SWISS PLUS IMPLANT SYSTEM | DZE | Substantially Equivalent | Sulzer Dental, Inc. | accessdata.fda.gov |
| May 21, 2001 | K011028 | SCREW-VENT DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Sulzer Dental, Inc. | accessdata.fda.gov |
| May 15, 2001 | K011038 | TAPER-LOCK DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Sulzer Dental, Inc. | accessdata.fda.gov |
| January 19, 2001 | K010073 | SPLINE DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Sulzer Calcitek, Inc. | accessdata.fda.gov |
| December 8, 2000 | K002614 | ADVENT IMPLANT SYSTEM | DZE | Substantially Equivalent | Core-Vent Corp. | accessdata.fda.gov |
| October 30, 2000 | K002188 | SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/OPAR,OPB 8,10,12,14/OP2.3D/OP2.8D, | DZE | Substantially Equivalent | Core-Vent Corp. | accessdata.fda.gov |
| June 21, 2000 | K001786 | TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG | DZE | Substantially Equivalent | Sulzer Calcitek, Inc. | accessdata.fda.gov |
| September 22, 1998 | K982305 | SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT | DZE | Substantially Equivalent | Sulzer Calcitek, Inc. | accessdata.fda.gov |
| August 26, 1997 | K972444 | 3I INNOVATIVE IMPLANTS AND COVER SCREWS | DZE | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| June 23, 1997 | K970752 | SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM | DZE | Substantially Equivalent | Sulzer Calcitek, Inc. | accessdata.fda.gov |
| August 29, 1996 | K962106 | SPLINE DENTAL IMPLANT SYSTEMS | DZE | Substantially Equivalent | Calcitek, Inc. | accessdata.fda.gov |
| March 8, 1996 | K955619 | 5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS | DZE | Substantially Equivalent | Calcitek, Inc. | accessdata.fda.gov |
| February 8, 1996 | K960021 | CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMS | DZE | Substantially Equivalent | Calcitek, Inc. | accessdata.fda.gov |
| February 8, 1996 | K943604 | INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Calcitek, Inc. | accessdata.fda.gov |
| December 21, 1995 | K953101 | PARAGON IMPLANT SYSTEM | DZE | Substantially Equivalent | Core-Vent Bio-Engineering, Inc. | accessdata.fda.gov |
| May 16, 1995 | K944327 | INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Calcitek, Inc. | accessdata.fda.gov |
| May 27, 1994 | K932123 | IMPLANT INNOVATION PRE-ANGLED ABUTMENT SYSTEM | DZE | Substantially Equivalent | Implant Innovations International, Inc. | accessdata.fda.gov |
| April 26, 1994 | K933969 | TAPERED ABUTMENT AND RELATED COMPONENTS | DZE | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| November 5, 1993 | K932274 | INTEGRAL III DENTAL IMPLANT ABUTMENT | DZE | Substantially Equivalent | Calcitek, Inc. | accessdata.fda.gov |
| February 11, 1992 | K912059 | PRE-ANGLED ABUTMENTS | DZE | Substantially Equivalent | Core-Vent Corp. | accessdata.fda.gov |
| February 20, 1991 | K900179 | SCREW-VENT ENDOSSEOUS IMPLANT ABUTMENTS | DZE | Substantially Equivalent | Core-Vent Corp. | accessdata.fda.gov |
| February 11, 1991 | K900694 | CASTABLE ABUTMENTS | DZE | Substantially Equivalent | Calcitek, Inc. | accessdata.fda.gov |
| December 17, 1990 | K902969 | SCREW-VENT ENDOSSEOUS HA COATED DENTAL IMPLANTS | DZE | Substantially Equivalent | Core-Vent Corp. | accessdata.fda.gov |
| November 9, 1990 | K904228 | OSSEODENT DENTAL ATTACHMENTS (NON-ANGLED) | DZE | Substantially Equivalent | Collagen Corp. | accessdata.fda.gov |
| June 28, 1990 | K900549 | INTEGRAL PLUS BIOINTEGRATED DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Calcitek, Inc. | accessdata.fda.gov |
| June 22, 1990 | K900545 | O-RING PROSTHETIC ATTACHMENT DEVICE | DZE | Substantially Equivalent | Calcitek, Inc. | accessdata.fda.gov |
| October 10, 1989 | K891613 | OVERDENTURE ATTACHMENT | DZE | Substantially Equivalent | Implant Innovations International, Inc. | accessdata.fda.gov |
| September 1, 1989 | K883717 | BIO-VENT | DZE | Substantially Equivalent | Core-Vent Corp. | accessdata.fda.gov |
| July 10, 1987 | K871863 | ADBUTMENT CYLINDER AND SCREW | DZE | Substantially Equivalent | Implant Innovations International, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 31, 2020 | 86402 | Class II | Terminated | BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ | 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 | accessdata.fda.gov |
| January 10, 2020 | 84771 | Class II | Terminated | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number: IEHA343 | 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 | accessdata.fda.gov |
| February 26, 2019 | 82263 | Class II | Terminated | CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible | 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. | accessdata.fda.gov |
| May 10, 2018 | 80609 | Class II | Terminated | Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10. Zimmer Dental Implants are designed for u | Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling. | accessdata.fda.gov |
| November 29, 2017 | 78667 | Class II | Terminated | Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10. | Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled. | accessdata.fda.gov |
| November 20, 2017 | 78635 | Class II | Terminated | Tapered Screw-Vent MTX Model TSVTB11 | Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition. | accessdata.fda.gov |
| October 11, 2017 | 78321 | Class II | Terminated | Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placemen | The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant. | accessdata.fda.gov |
| July 10, 2017 | 77911 | Class II | Terminated | Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223 | Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs. | accessdata.fda.gov |
| March 20, 2017 | 76746 | Class II | Terminated | Tapered SwissPlus Implant System, Model No. SPB10 | It was manufactured with the minor diameter of the internal thread that is below specification. | accessdata.fda.gov |
| March 8, 2017 | 76809 | Class II | Terminated | BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile" | 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 | accessdata.fda.gov |
| September 14, 2016 | 75761 | Class II | Terminated | 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 a | A limited number of product pouches may not have been sealed during packaging. | accessdata.fda.gov |
| August 8, 2016 | 74896 | Class II | Terminated | 3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only. | Product was incorrectly packaged. | accessdata.fda.gov |
| January 6, 2016 | 73013 | Class II | Terminated | IMPLANT,TM, MTX 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMM4B10 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional heali | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. | accessdata.fda.gov |
| November 25, 2015 | 73184 | Class II | Terminated | Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H) Item: IWTH52 Dental implants | Pouches may not have been sealed during packing. | accessdata.fda.gov |
| November 16, 2015 | 72658 | Class II | Terminated | Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants. | Images contained within radiographic transparency ART 1036 are undersized. | accessdata.fda.gov |
| September 21, 2015 | 72446 | Class II | Terminated | BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. | Inadequate biocompatibility testing. | accessdata.fda.gov |
| August 10, 2015 | 72368 | Class II | Terminated | Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver tips are attached to a surgical drilling unit to carry components such as implant mounts, healing abutments and screws for placement and removal. For dental a | The RASH3N, a hexed, abutment screw driver tip has been labeled and distributed as RASQ3N, a square, abutment screw driver tip. Additionally, the RASQ3N received the RASH3N's laser marking "RASH3N" during manufacturing. | accessdata.fda.gov |
| July 29, 2015 | 72000 | Class II | Terminated | UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient. | MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexed, castable abutment cylinders for this one lot only. | accessdata.fda.gov |
| January 22, 2015 | 70304 | Class II | Terminated | GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits, Surgical, Complete, Catalog OPCST; Tapered Screw-Vent Implant System Surgical Kit, Complete, Catalo | The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the implant. | accessdata.fda.gov |
| November 7, 2014 | 70628 | Class II | Terminated | 3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm Dental Implants. | Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored. | accessdata.fda.gov |
| October 1, 2014 | 69392 | Class II | Terminated | Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conven | Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial. | accessdata.fda.gov |
| June 25, 2014 | 68915 | Class II | Terminated | BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration. | Identifiers on the label are correct but the label has the incorrect color coding. | accessdata.fda.gov |
| January 6, 2014 | 67207 | Class II | Terminated | Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227. | Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog TSVWB11, Lot 62470008, because some of the packages of this lot may have the Cap Label state 3.7 x 10mm instead of 4.7 x 11.5mm. | accessdata.fda.gov |
| October 3, 2013 | 67194 | Class III | Terminated | ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or transplantation when bone is lost due to trauma or requested during | Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have an incorrect label with the wrong batch number. | accessdata.fda.gov |
| August 29, 2013 | 67609 | Class II | Terminated | BIOMET 3i Endosseous Dental Implant. | Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental implant surface. | accessdata.fda.gov |
| August 26, 2013 | 66787 | Class II | Terminated | Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA ***EDAZ, EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Abutment; Abutment; Pilastro; Pilar*** | Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received. | accessdata.fda.gov |
| July 22, 2013 | 67183 | Class II | Terminated | Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing. | During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required. | accessdata.fda.gov |
| June 10, 2013 | 66204 | Class II | Terminated | Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in par | One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature. | accessdata.fda.gov |
| May 10, 2013 | 65005 | Class II | Terminated | Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L) | A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, is label correctly. This condition, if present and not recognized could potentially result in the dental implant not being able to be placed into the osteotomy or seated to the desired depth if placement is attempted. | accessdata.fda.gov |
| September 28, 2012 | 63618 | Class II | Terminated | Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 13 mm. The product is sterile. Product provides a means for prosthetic attachment in single tooth restorations and in partially or | Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This condition may prevent the driver or abutment from fully engaging in the implant. | accessdata.fda.gov |
| August 3, 2012 | 63313 | Class II | Terminated | Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations an | Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percentage of the devices are missing the internal threading. | accessdata.fda.gov |
| May 31, 2012 | 62578 | Class II | Terminated | Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable Cylinder***Cylinder; Cylindre; Zylinder; Cilindro; Cilindro; Cilindro***RX | Biomet 3i conducted a recall on the device Low Profile Abutment, Non-Hexed Castable Cylinder due to some packages labeled LPCCC1, Hexed Castable Cylinder possibly containing LPCCC2, Non-Hexed Castable Cylinders. | accessdata.fda.gov |
| March 23, 2012 | 62375 | Class II | Terminated | REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) S | Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611. The depth of the implant's internal hex is too shallow. The condition, if present, may prevent the driver; cover screw or abutment from fully engaging the implant. | accessdata.fda.gov |
| January 10, 2012 | 61473 | Not yet classified | Terminated | Certain Low-Profile, Angled Abutment, Model Number ILPAC3217. Product is labeled in part: "***Biomet 3i***4555 Riverside Drive, Palm Beach Gardens, FL 33410 USA***REF ILPAC3217***LOT 2011091179***Certain Low Profile 17 A | Biomet 3i initiated a recall for a small percentage of the 33mm (ILPAC3217) abutment packages that may contain the 5mm (ILPAC5217) abutment. | accessdata.fda.gov |
| November 4, 2011 | 61376 | Class II | Terminated | Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection.. Product is labeled in part: "***Certain 3.25, 13***REF IOSM313 LOT*** OSSEOTITE Certain Implant***3.25 x 13mm***CE 0086***Use by yyyy-mm***S | On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. Dental implant lot may not have an internal thread. | accessdata.fda.gov |
| September 28, 2011 | 60254 | Not yet classified | Terminated | "***BIOMET 3i***4555 Riverside Drive Palm Beach Gardens FL 33410 USA***REF AC4425***Conical 25 ANGLED ABUTMENT***4.1mm(D) X 4mm(H)***Abutment; Pilier: Abutment; Abutment; Pilastro; Pilar***RX Only***Sterile***BIOMET 3i D | On 09/28/2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Conical Angled Abutment, Model # AC4425 Lot 887628-5 and their Standard Conical Abutment Cylinder Model # SWCA62 Lot 848478. The packaging for the referenced products may not have been completely sealed prior to shipment. | accessdata.fda.gov |
| March 14, 2011 | 58921 | Not yet classified | Terminated | LPCCC2: Low Profile Abutment Non-Hexed Castable Cylinder by Biomet 3i Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast | Biomet 3i, Palm Beach Gardens, FL is recalling the Model LPCCC2 Low Profile Abutment, Non-Hexed Castable Cylinder, Lots 2010101036 and 2010101037 Exp. 10/2015. Package labeling may not correctly describe the package contents. Product was distributed in Europe only. | accessdata.fda.gov |
| March 10, 2011 | 58328 | Not yet classified | Terminated | REF INT411***OSSEOTITE Tapered Certain Implant 4 x 11.5mm***Sterile Using Radiation***Rx Only***BIOMET 3i Dental lberica S.L.WTC Almeda Park, Ed, 1 Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain* | Biomet 3i is recalling their product Osseotite NT Certain Dental Implant INT411. The internal thread was not manufactured correctly. | accessdata.fda.gov |
| March 10, 2011 | 58326 | Not yet classified | Terminated | REF IOSS413*** OSSEIOTITE Certain Implant 4 x 13mm*** Sterile using Radiation*** Rx Only***BIOMET 3i Dental Iberica S.L.WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain*** B | Biomet 3i is recalling their product Osseotite Certain Implant Device IOSS413. The internal thread was not manufactured correctly. | accessdata.fda.gov |
| December 1, 2010 | 58769 | Not yet classified | Terminated | "***3i Incise Custom-Made Label. QP157 Approved 07/09/10*** 3i inc se Custom-made Dental Framework***Biomet 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410 www.biomet3i.com Please consult instructions for use and re | On December 1, 2010 Biomet 3i recalled their product Incise Zirconia Coping (CBZR0102). The Coping contains a manufacturing defect. Coping is oversized. All affected direct accounts were notified by letter on December 14, 2010. | accessdata.fda.gov |
| November 18, 2010 | 58766 | Not yet classified | Terminated | REF IOSS511***OSSEOTITE Certain Implant 5 x 11.5mm***LOT 910695***Sterile using Radiation***Rx Only***BIOMET 3i Dental Iberica S.L.WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n 08940 Cornella de Llobregat (Barcelona | The product may contain a manufacturing defect, that if present, may prevent the driver; cover screw or abutment from fully engaging the implant. | accessdata.fda.gov |
| February 23, 2010 | 58768 | Not yet classified | Terminated | "***REF IWTH56***Certain EP HEALING ABUTMENT 5mm(D) X 5mm(P) X 6mm(H).*** Healing abutment*** STERILE.***Rx Only.*** Made in USA*** Implant Innovations, Inc. Global Headquarters 4555 Riverside Drive, Palm Beach Gardens, | Biomet 3i of Palm Beach Gardens, FL is recalling their Certain EP Healing Abutment (IWTH56). The Healing Abutment dimensions did not match outside label and laser etching on part. The product was actually 8mm but the package indicated 6mm. | accessdata.fda.gov |
| November 23, 2009 | 54074 | Not yet classified | Terminated | LOCATOR Restorative Abutment, ILOA002, LOT 877423, Certain LOCATOR ABUTMENT, 4.1 mm(D) X 2mm(H), STERILE Made in USA, Sterile. BIOMET 3i 4555 Riverside Drive, Palm Beach Gardens, FL 33410 USA. For use on tissue supported | Package labeled as sterile may have an incomplete or partial seal thereby possibly compromising sterility. | accessdata.fda.gov |
| October 6, 2009 | 54371 | Not yet classified | Terminated | BIOMET 3i GS300 GOLD SLOTTED SCREW-3mm, STERILE, Rx Only. Made in USA. Lots 868517, 865348, and 868515. BIOMET 3i, 4555 Riverside Dr., Palm Beach Gardens, FL. | Biomet 3i, Palm Beach Gardens, FL is recalling their Gold Slotted Retaining Screw 3MM, Model Number GS300. Product is Out Of Specification - product was manufactured with a material not specified for use in this product. | accessdata.fda.gov |
| June 29, 2009 | 52604 | Not yet classified | Terminated | ACT3020 Advanced Cutting technology (ACT) Twist Drill 3.0mm(D) X 20mm(L). BIOMET 3i 455 Riverside Drive, Palm Beach Gardens, FL 33410 USA. Made in Switzerland. Twist drill for preparation of osteotomy during dental impla | Some of the packages of ACT3020, drills may actually contain an ACT3220 drill. | accessdata.fda.gov |
| May 9, 2008 | 48677 | Not yet classified | Terminated | Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. The product is used for CT guided surgery. | The drill malfunctions while in use. The drill has been observed to become lodged in the handle. | accessdata.fda.gov |
| February 14, 2008 | 47342 | Not yet classified | Terminated | BIOMET 3i, EP Healing Abutment, REF/Item Number: THA53, 4.1mm(D) X 5mm(P) X 3mm(H), Sterile, BIOMET 3i, Palm Beach, FL | Mis-labeling: Labeled THA53 device packaging may contain ITHA53 devices (The ITHA53 is designed to be used with an internally hexed implant--The THA53 is used with an external hex platform) | accessdata.fda.gov |
| February 7, 2008 | 47340 | Not yet classified | Terminated | BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA002, 2.0mm, BioMet 3i, Palm Beach, FL. | Mispackaging: The Locator Abutment labeled as LOA002 may contain Catalog/Item # LOA003 product and visa versa | accessdata.fda.gov |
| February 6, 2008 | 47341 | Not yet classified | Terminated | BIOMET 3i Certain MicroMiniplant Straight Healing Abutment, Model/Item Number: ISMHA32, 3.4mm(D) X 0mm(P) X 2mm(H), BioMet 3i, Palm Gardens, FL. | Seating Problems: The Micro-miniplant Straight Healing Abutments do not fully seat onto the restorative platform of the implant leaving a gap between the abutment and the implant. | accessdata.fda.gov |
| October 8, 2007 | 45431 | Not yet classified | Terminated | Biomet 3i, Certain PreFormance Temporary Cylinder, Catalog Number: IPFTC42, Dental Implant, Biomet 3i, Palm Beach Gardens, FL 33410 | Incorrect assembly: The product does not allow for the screw to pass through the access hole and engage the implant properly. Therefore, the provisional restoration will not be seated on the implant platform. | accessdata.fda.gov |
| August 3, 2007 | 38983 | Not yet classified | Terminated | Product is labeled as LTX XP Miniplant, Dental Implant, Sterile. | The LTX XP Miniplant, BIOMET 3i dental implant, was labeled incorrectly. The 13MM implants were labeled and packaged as 11.5MM implants and 11.5MM implants were labeled and packaged as 13MM implants. | accessdata.fda.gov |
| May 14, 2007 | 37994 | Not yet classified | Terminated | Biomet 3 i, Disposable Twist Drills, Model Number DT2715. | The depth indicator laser line markings on the drills are too faint for clinicians to read during use. | accessdata.fda.gov |
| April 25, 2007 | 37865 | Not yet classified | Terminated | Certain MicroMiniplant Straight Healing Abutment. Dental implant. Model numbers: ISMHA32, ISMHA33, ISMHA34 and ISMHA36. | The Straight Healing Abutment did not fully seat to the restorative platform of the implant, leaving a gap between the abutment and the implant. | accessdata.fda.gov |
| December 11, 2006 | 52631 | Not yet classified | Terminated | 3i Custom # 5753, OSCM2913, 2.9MMX 3.4MM X 13MM, OSSEOTITE CUSTOM, MICROMINI IMPLANT, LOT # 470258, Sterile. Implant Innovations, Inc. 4555 Riverside Drive, Palm Beach Gardens, FL 33410. Custom temporary cover screws are | Healing Abutment was not made within required manufacturing specification. The product did not have the relief behind the thread, which does not allow proper seating. | accessdata.fda.gov |
| October 16, 2006 | 36616 | Not yet classified | Terminated | EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly connected to an endosseous dental implant. | Package Integrity; sterility compromised-Incomplete seals on the nylon bags in which the product is packed. | accessdata.fda.gov |
| October 4, 2004 | 30203 | Not yet classified | Terminated | EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant. | The nylon bag holding the product was not completely sealed before sterilization. Patients could be infected if the abutment is implanted. | accessdata.fda.gov |
| January 13, 2004 | 28217 | Not yet classified | Terminated | Advent Implant Line | Sterility barrier compromised. | accessdata.fda.gov |
| December 2, 2003 | 28092 | Not yet classified | Terminated | Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA DC500 LOT 5.0mm Implant | The tray lid seals may be open thereby compromising the sterility barriers for the recalled lots. | accessdata.fda.gov |
| May 9, 2003 | 26370 | Not yet classified | Terminated | Product is a drill used in dental surgery labeled in part: OFDR8 OsseoFix Drill 8mm Length 3i Implant Innovations, Inc. 4555 Riverside drive, Palm Beach Gardens, FL 33410 Non Sterile Contents must be sterilized prior to | Some 8mm OsseoFix drills included in the kit may be incorrectly laser marked as 4mm OsseoFix drills. | accessdata.fda.gov |
| January 28, 2003 | 25722 | Not yet classified | Terminated | LTX Endosseous Implant 6.0 mm X 11.5 mm and also LTX Endosseous Implant 5.0 mm X 15 mm, Sterile | Sterile Endosseous implants may be packaged in mislabeled packaging with the incorrect size. | accessdata.fda.gov |
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Updated October 23, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.