Browse Device Recalls

222 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 222 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 222 FDA device recalls.

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Date	Product	Reason	Class	Firm
Nov 7, 2014	3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm ...	Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be dis...	Class II	Biomet 3i, LLC
Nov 7, 2014	OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.	Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be dis...	Class II	Biomet 3i, LLC
Nov 7, 2014	OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental ...	Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be dis...	Class II	Biomet 3i, LLC
Jun 25, 2014	BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abut...	Identifiers on the label are correct but the label has the incorrect color coding.	Class II	Biomet 3i, LLC
Oct 3, 2013	ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bo...	Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitut...	Class III	Biomet 3i, LLC
Aug 29, 2013	BIOMET 3i Endosseous Dental Implant.	Due to residual machining fluid identified by discoloration (darker in appearance) on the externa...	Class II	Biomet 3i, LLC
Aug 26, 2013	Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL...	Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received.	Class II	Biomet 3i, LLC
Jul 22, 2013	Contra-Angle Torque Driver Kit For Certain and External Connection Product...	During recent revised sterilization validation testing, the included surgical trays did not meet ...	Class II	Biomet 3i, LLC
Jul 22, 2013	Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usa...	During recent revised sterilization validation testing, the included surgical trays did not meet ...	Class II	Biomet 3i, LLC
Jul 22, 2013	Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in...	During recent revised sterilization validation testing, the included surgical trays did not meet ...	Class II	Biomet 3i, LLC
Jul 22, 2013	Navigator Surgical Kit Product Usage: Molded plastic tray used in holding...	During recent revised sterilization validation testing, the included surgical trays did not meet ...	Class II	Biomet 3i, LLC
Jul 22, 2013	Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray...	During recent revised sterilization validation testing, the included surgical trays did not meet ...	Class II	Biomet 3i, LLC
Jun 10, 2013	Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant Product ...	One of the dental implants do not have the internal hex feature. One of the dental implants do n...	Class II	Biomet 3i, LLC
Jun 10, 2013	Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant ...	One of the dental implants do not have the internal hex feature. One of the dental implants do n...	Class II	Biomet 3i, LLC
May 10, 2013	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, ...	Class II	Biomet 3i, LLC
May 10, 2013	Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (...	A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, ...	Class II	Biomet 3i, LLC
Sep 28, 2012	Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, a...	Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Ce...	Class II	Biomet 3i, LLC
Sep 28, 2012	Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA4...	Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Ce...	Class II	Biomet 3i, LLC
Aug 3, 2012	Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental I...	Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percen...	Class II	Biomet 3i, LLC
May 31, 2012	Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is l...	Biomet 3i conducted a recall on the device Low Profile Abutment, Non-Hexed Castable Cylinder due ...	Class II	Biomet 3i, LLC
Mar 23, 2012	*REF IFNT611Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm**Sterile ...	Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611. The depth o...	Class II	Biomet 3i, LLC
Nov 4, 2011	Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection...	On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certa...	Class II	Biomet 3i, LLC

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.