Zimmer Dental Recalls
33 recalls on record · February 5, 2014 to September 12, 2018 · Medical Devices
Recalls by year
14
15
16
17
18
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 12, 2018Medical DevicesFDA
Zimmer Dental Inc recalls Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Pac
Hazard: 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.
April 4, 2018Medical DevicesFDA
Zimmer Dental Inc recalls Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
Hazard: Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
April 4, 2018Medical DevicesFDA
Zimmer Dental Inc recalls Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.
Hazard: Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
December 27, 2017Medical DevicesFDA
Zimmer Dental Inc recalls Tapered Screw-Vent MTX Model TSVTB11
Hazard: Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.
December 27, 2017Medical DevicesFDA
Zimmer Dental Inc recalls Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete, Ref TSVKIT. The label sh
Hazard: 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.
December 27, 2017Medical DevicesFDA
Zimmer Dental Inc recalls Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, starter, Ref STRKIT. The label sho
Hazard: 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.
December 27, 2017Medical DevicesFDA
Zimmer Dental Inc recalls Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The label shows the product is Manu
Hazard: 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.
December 27, 2017Medical DevicesFDA
Zimmer Dental Inc recalls Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, C
Hazard: 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.
October 4, 2017Medical DevicesFDA
Zimmer Dental Inc recalls IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11; IMPLANT, 1 -PC,ANG,3.0X13MM
Hazard: 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.
October 4, 2017Medical DevicesFDA
Zimmer Dental Inc recalls WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; WAXING COPING, CONT 3.5 MM, REF ZOCWAX3S; WAXING COPING, CONT 4.5MM, ANG
Hazard: 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.
October 4, 2017Medical DevicesFDA
Zimmer Dental Inc recalls IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; MPRESSION CAP CONT 3.5MM, REF ZOCIMP3S; IMPRESSION CAP CONT 4.5MM ANG, RE
Hazard: 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.
October 4, 2017Medical DevicesFDA
Zimmer Dental Inc recalls TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34; TRY-IN, ABUTMENT, CONT, 4.5X5.5, REF ZOAT45; TRY-IN, ABUTMENT, CONT, 5
Hazard: 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.
October 4, 2017Medical DevicesFDA
Zimmer Dental Inc recalls ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REF HLA5G; COPING GOLD
Hazard: 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.
October 4, 2017Medical DevicesFDA
Zimmer Dental Inc recalls THREAD RETRIEVAL DRILL REF 2224
Hazard: 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.
October 4, 2017Medical DevicesFDA
Zimmer Dental Inc recalls Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
Hazard: 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.
April 26, 2017Medical DevicesFDA
Zimmer Dental Inc recalls Tapered SwissPlus Implant System, Model No. SPB10
Hazard: It was manufactured with the minor diameter of the internal thread that is below specification.
February 17, 2016Medical DevicesFDA
Zimmer Dental Inc recalls IMPLANT,TM, MTX FULL 3.7 mm x 16 mm diameter 3.5 mm Catalog #TMTB16 Product Usage: Zimmer Dental implant systems
Hazard: 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.
February 17, 2016Medical DevicesFDA
Zimmer Dental Inc recalls IMPLANT,TM, MTX FULL 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMTB13 Product Usage: Zimmer Dental implant systems
Hazard: 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.
February 17, 2016Medical DevicesFDA
Zimmer Dental Inc recalls IMPLANT,TM, MTX FULL 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMTB11 Product Usage: Zimmer Dental implant system
Hazard: 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.
February 17, 2016Medical DevicesFDA
Zimmer Dental Inc recalls IMPLANT,TM, MTX FULL 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMTB10 Product Usage: Zimmer Dental implant systems
Hazard: 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.
February 17, 2016Medical DevicesFDA
Zimmer Dental Inc recalls IMPLANT,TM, MTX FULL 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMT4B13 Product Usage: Zimmer Dental implant systems
Hazard: 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.
February 17, 2016Medical DevicesFDA
Zimmer Dental Inc recalls IMPLANT,TM, MTX FULL 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMT4B11 Product Usage: Zimmer Dental implant syste
Hazard: 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.
February 17, 2016Medical DevicesFDA
Zimmer Dental Inc recalls IMPLANT,TM, MTX FULL 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMT4B10 Product Usage: Zimmer Dental implant systems
Hazard: 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.
February 17, 2016Medical DevicesFDA
Zimmer Dental Inc recalls IMPLANT,TM, MTX 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMMB13 Product Usage: Zimmer Dental implant systems are d
Hazard: 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.
February 17, 2016Medical DevicesFDA
Zimmer Dental Inc recalls IMPLANT,TM, MTX 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMMB11 Product Usage: Zimmer Dental implant systems are
Hazard: 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.
February 17, 2016Medical DevicesFDA
Zimmer Dental Inc recalls IMPLANT,TM, MTX 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMMB10 Product Zimmer Dental implant systems are designed
Hazard: 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.
February 17, 2016Medical DevicesFDA
Zimmer Dental Inc recalls IMPLANT,TM, MTX 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMM4B13 Product Usage: Zimmer Dental implant systems are
Hazard: 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.
February 17, 2016Medical DevicesFDA
Zimmer Dental Inc recalls IMPLANT,TM, MTX 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMM4B11 Product Usage: Zimmer Dental implant systems ar
Hazard: 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.
February 17, 2016Medical DevicesFDA
Zimmer Dental Inc recalls IMPLANT,TM, MTX 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMM4B10 Product Usage: Zimmer Dental implant systems are
Hazard: 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.
February 18, 2015Medical DevicesFDA
Zimmer Dental Inc recalls GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits,
Hazard: The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the implant.