Recall archive
23 recalls · page 1 of 1
Reported Oct 14, 2020
BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand — Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 4, 2020
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number: IEHA343
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand — Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or…
22 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2019
CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product · Product details — During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 5, 2017
BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product · Product details — 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…
FDA (openFDA device enforcement)
Reported Dec 28, 2016
BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product · Product details — A limited number of product pouches may not have been sealed during packaging.
35 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 28, 2016
3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product · Product details — Product was incorrectly packaged.
FDA (openFDA device enforcement)
Reported Aug 24, 2016
Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H) Item: IWTH52 Dental implants
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand — Pouches may not have been sealed during packing.
118 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 13, 2016
BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product · Product details — Inadequate biocompatibility testing.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 6, 2016
Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand — Images contained within radiographic transparency ART 1036 are undersized.
FDA (openFDA device enforcement)
Reported Nov 18, 2015
Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver tips are attached to a surgical drilling unit to carry…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product · Product details — The RASH3N, a hexed, abutment screw driver tip has been labeled and distributed as RASQ3N, a square, abutment screw driver tip. Additionally, the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 23, 2015
UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand — MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexed, castable abutment cylinders for this one lot only.
FDA (openFDA device enforcement)
Reported Apr 22, 2015
3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm Dental Implants.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product · Product details — Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 17, 2014
BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product · Product details — Identifiers on the label are correct but the label has the incorrect color coding.
FDA (openFDA device enforcement)
Reported Apr 23, 2014
BIOMET 3i Endosseous Dental Implant.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product · Product details — Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental implant surface.
FDA (openFDA device enforcement)
Reported Mar 26, 2014
Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product details · Reason for recall — Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 19, 2014
Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand — During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2013
Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: Surgical placement in the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand — One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 21, 2013
Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product · Product details — A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, is label correctly. This condition, if present and…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 28, 2012
Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 13 mm. The product is sterile.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Reason for recall — Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 31, 2012
Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product · Product details · Reason for recall — Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percentage of the devices are missing the internal…
FDA (openFDA device enforcement)
Reported Sep 5, 2012
Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Reason for recall — Biomet 3i conducted a recall on the device Low Profile Abutment, Non-Hexed Castable Cylinder due to some packages labeled LPCCC1, Hexed Castable…
FDA (openFDA device enforcement)
Reported Aug 15, 2012
***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product · Product details · Reason for recall — Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611. The depth of the implant's internal hex is too shallow. The…
FDA (openFDA device enforcement)
Reported Jun 27, 2012
Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product details · Reason for recall — On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. Dental…
FDA (openFDA device enforcement)
RecallNow is not a government agency. Every notice above is published by the FDA, USDA FSIS, or CPSC and links back to its source. Back to the look-up