Browse Device Recalls

33 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 33 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 33 FDA device recalls.

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DateProductReasonClassFirm
May 10, 2018 Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, ... Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct i... Class II Zimmer Dental Inc
Nov 29, 2017 Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10. Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvert... Class II Zimmer Dental Inc
Nov 29, 2017 Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10. Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvert... Class II Zimmer Dental Inc
Nov 20, 2017 Tapered Screw-Vent MTX Model TSVTB11 Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a man... Class II Zimmer Dental Inc
Oct 11, 2017 Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgic... The device may contain a manufacturing condition affecting the geometry of the driver's hex featu... Class II Zimmer Dental Inc
Oct 11, 2017 Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgic... The device may contain a manufacturing condition affecting the geometry of the driver's hex featu... Class II Zimmer Dental Inc
Oct 11, 2017 Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref... The device may contain a manufacturing condition affecting the geometry of the driver's hex featu... Class II Zimmer Dental Inc
Oct 11, 2017 Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manu... The device may contain a manufacturing condition affecting the geometry of the driver's hex featu... Class II Zimmer Dental Inc
Jul 10, 2017 THREAD RETRIEVAL DRILL REF 2224 Zimmer Biomet is conducting a medical device field correction for various dental products due to ... Class II Zimmer Dental Inc
Jul 10, 2017 IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; MPRESSION CAP CONT 3.5MM, REF ZOC... Zimmer Biomet is conducting a medical device field correction for various dental products due to ... Class II Zimmer Dental Inc
Jul 10, 2017 TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34; TRY-IN, ABUTMENT, CONT, 4.5X5.... Zimmer Biomet is conducting a medical device field correction for various dental products due to ... Class II Zimmer Dental Inc
Jul 10, 2017 WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; WAXING COPING, CONT 3.5 MM, RE... Zimmer Biomet is conducting a medical device field correction for various dental products due to ... Class II Zimmer Dental Inc
Jul 10, 2017 ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPI... Zimmer Biomet is conducting a medical device field correction for various dental products due to ... Class II Zimmer Dental Inc
Jul 10, 2017 Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222... Zimmer Biomet is conducting a medical device field correction for various dental products due to ... Class II Zimmer Dental Inc
Jul 10, 2017 IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, R... Zimmer Biomet is conducting a medical device field correction for various dental products due to ... Class II Zimmer Dental Inc
Mar 20, 2017 Tapered SwissPlus Implant System, Model No. SPB10 It was manufactured with the minor diameter of the internal thread that is below specification. Class II Zimmer Dental Inc
Jan 6, 2016 IMPLANT,TM, MTX FULL 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMT4B13 Pr... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 6, 2016 IMPLANT,TM, MTX FULL 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMTB10 Pro... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 6, 2016 IMPLANT,TM, MTX FULL 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMTB13 Pro... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 6, 2016 IMPLANT,TM, MTX FULL 3.7 mm x 16 mm diameter 3.5 mm Catalog #TMTB16 Pro... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 6, 2016 IMPLANT,TM, MTX 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMM4B10 Product... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 6, 2016 IMPLANT,TM, MTX FULL 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMT4B11 ... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 6, 2016 IMPLANT,TM, MTX 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMM4B13 Product... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 6, 2016 IMPLANT,TM, MTX 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMMB10 Product ... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 6, 2016 IMPLANT,TM, MTX FULL 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMTB11 P... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 6, 2016 IMPLANT,TM, MTX 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMMB13 Product ... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 6, 2016 IMPLANT,TM, MTX 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMM4B11 Produ... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 6, 2016 IMPLANT,TM, MTX 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMMB11 Produc... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 6, 2016 IMPLANT,TM, MTX FULL 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMT4B10 Pr... Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... Class II Zimmer Dental Inc
Jan 22, 2015 GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered ... The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex... Class II Zimmer Dental Inc
Oct 1, 2014 Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spl... Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was pr... Class II Zimmer Dental Inc
Oct 1, 2014 Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No. TS... Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was pr... Class II Zimmer Dental Inc
Jan 6, 2014 Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Numb... Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant,... Class II Zimmer Dental Inc

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.