Zimmer Dental recalls

Zimmer Dental appears in 33 official U.S. recall notices indexed by RecallRadar, most recently on 2018-09-12.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only
  FDA Device · Class II · 2018-09-12 · Zimmer Dental
  Reason: 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.
• Tapered Screw-Vent MTX, Dental Implant, sterile
  FDA Device · Class II · 2018-04-04 · Zimmer Dental
  Reason: Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
• Tapered Screw-Vent MTX, Dental Implant, sterile
  FDA Device · Class II · 2018-04-04 · Zimmer Dental
  Reason: Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
• Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The label shows the product is Manufactured by Zimmer…
  FDA Device · Class II · 2017-12-27 · Zimmer Dental
  Reason: 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.
• Tapered Screw-Vent MTX Model TSVTB11
  FDA Device · Class II · 2017-12-27 · Zimmer Dental
  Reason: Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.
• Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, starter, Ref STRKIT. The label shows the product is Ma…
  FDA Device · Class II · 2017-12-27 · Zimmer Dental
  Reason: 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.
• Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete, Ref TSVKIT. The label shows the product is M…
  FDA Device · Class II · 2017-12-27 · Zimmer Dental
  Reason: 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.
• Zimmer Dental GemLock RHD2.5 Hex Driver
  FDA Device · Class II · 2017-12-27 · Zimmer Dental
  Reason: 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.
• TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34
  FDA Device · Class II · 2017-10-04 · Zimmer Dental
  Reason: 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.
• THREAD RETRIEVAL DRILL REF 2224
  FDA Device · Class II · 2017-10-04 · Zimmer Dental
  Reason: 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.
• ABUT GOLD FRICTION-FIT, REF HLA3G
  FDA Device · Class II · 2017-10-04 · Zimmer Dental
  Reason: 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.
• Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
  FDA Device · Class II · 2017-10-04 · Zimmer Dental
  Reason: 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.
• IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10
  FDA Device · Class II · 2017-10-04 · Zimmer Dental
  Reason: 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.
• IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A
  FDA Device · Class II · 2017-10-04 · Zimmer Dental
  Reason: 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.
• WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A
  FDA Device · Class II · 2017-10-04 · Zimmer Dental
  Reason: 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.
• Tapered SwissPlus Implant System, Model No. SPB10
  FDA Device · Class II · 2017-04-26 · Zimmer Dental
  Reason: It was manufactured with the minor diameter of the internal thread that is below specification.
• IMPLANT,TM, MTX 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMM4B13 Product Usage: Zimmer Dental implant systems are designed for use in the ma…
  FDA Device · Class II · 2016-02-17 · Zimmer Dental
  Reason: 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.
• IMPLANT,TM, MTX FULL 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMTB10 Product Usage: Zimmer Dental implant systems are designed for use in th…
  FDA Device · Class II · 2016-02-17 · Zimmer Dental
  Reason: 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.
• IMPLANT,TM, MTX 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMMB13 Product Usage: Zimmer Dental implant systems are designed for use in the max…
  FDA Device · Class II · 2016-02-17 · Zimmer Dental
  Reason: 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.
• IMPLANT,TM, MTX 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMM4B11 Product Usage: Zimmer Dental implant systems are designed for use in the…
  FDA Device · Class II · 2016-02-17 · Zimmer Dental
  Reason: 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.
• IMPLANT,TM, MTX FULL 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMTB13 Product Usage: Zimmer Dental implant systems are designed for use in th…
  FDA Device · Class II · 2016-02-17 · Zimmer Dental
  Reason: 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.
• IMPLANT,TM, MTX FULL 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMT4B10 Product Usage: Zimmer Dental implant systems are designed for use in t…
  FDA Device · Class II · 2016-02-17 · Zimmer Dental
  Reason: 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.
• IMPLANT,TM, MTX FULL 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMTB11 Product Usage: Zimmer Dental implant systems are designed for use in…
  FDA Device · Class II · 2016-02-17 · Zimmer Dental
  Reason: 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.
• IMPLANT,TM, MTX FULL 3.7 mm x 16 mm diameter 3.5 mm Catalog #TMTB16 Product Usage: Zimmer Dental implant systems are designed for use in th…
  FDA Device · Class II · 2016-02-17 · Zimmer Dental
  Reason: 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.
• 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 ma…
  FDA Device · Class II · 2016-02-17 · Zimmer Dental
  Reason: 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.
• IMPLANT,TM, MTX FULL 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMT4B13 Product Usage: Zimmer Dental implant systems are designed for use in t…
  FDA Device · Class II · 2016-02-17 · Zimmer Dental
  Reason: 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.
• IMPLANT,TM, MTX 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMMB10 Product Zimmer Dental implant systems are designed for use in the maxilla or…
  FDA Device · Class II · 2016-02-17 · Zimmer Dental
  Reason: 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.
• IMPLANT,TM, MTX 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMMB11 Product Usage: Zimmer Dental implant systems are designed for use in the m…
  FDA Device · Class II · 2016-02-17 · Zimmer Dental
  Reason: 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.
• IMPLANT,TM, MTX FULL 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMT4B11 Product Usage: Zimmer Dental implant systems are designed for use in…
  FDA Device · Class II · 2016-02-17 · Zimmer Dental
  Reason: 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.
• GemLock Long Hex Driver, Catalog RHL2.5
  FDA Device · Class II · 2015-02-18 · Zimmer Dental
  Reason: The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the implant.
• Spline Twist Implant, HA 3.25mmD X 15mmL
  FDA Device · Class II · 2014-11-05 · Zimmer Dental
  Reason: Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.
• Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No. TSV4B10 Tapered Screw-Vent Implant, MTX, 4.1mmD X 11.5mmL X 3.5mm…
  FDA Device · Class II · 2014-11-05 · Zimmer Dental
  Reason: Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.
• Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform
  FDA Device · Class II · 2014-02-05 · Zimmer Dental
  Reason: 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 instea…