BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is i...
Reason: A limited number of product pouches may not have been sealed during packaging.
BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intend...
Reason: A limited number of product pouches may not have been sealed during packaging.
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is i...
Reason: A limited number of product pouches may not have been sealed during packaging.
Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Femoral Integral Shaft & Stem 30x27 HA Coated; Femoral Integral Shaft & Stem 30x30 HA Coated The ...
Reason: The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's ste...
Z-0823-2017December 28, 2016Borehamwood, N/A
Stanmore Implants Worldwide Ltd.
Class IITerminated
Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the...
Reason: The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's ste...
Z-0820-2017December 28, 2016Borehamwood, N/A
Biomet 3i, LLC
Class IITerminated
BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and i...
Reason: A limited number of product pouches may not have been sealed during packaging.
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant ...
Reason: A limited number of product pouches may not have been sealed during packaging.
Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, d...
Reason: The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's ste...
Z-0822-2017December 28, 2016Borehamwood, N/A
Biomet 3i, LLC
Class IITerminated
BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is int...
Reason: A limited number of product pouches may not have been sealed during packaging.
BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and i...
Reason: A limited number of product pouches may not have been sealed during packaging.
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is i...
Reason: A limited number of product pouches may not have been sealed during packaging.
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant ...
Reason: A limited number of product pouches may not have been sealed during packaging.
BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended fo...
Reason: A limited number of product pouches may not have been sealed during packaging.
BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and i...
Reason: A limited number of product pouches may not have been sealed during packaging.
BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is int...
Reason: A limited number of product pouches may not have been sealed during packaging.
BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is inte...
Reason: A limited number of product pouches may not have been sealed during packaging.
Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant
Reason: It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery.
Reason: Sorin Group USA, Inc. announces a voluntary field action for the Perceval Sutureless Heart Valve due to updated steps associated with the implantation procedure.
Z-0716-2017December 14, 2016Arvada, CO
Tornier, Inc
Class IITerminated
Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272...
Reason: Tornier is conducting a recall on Aequalis Fx2 ( implant parts and instrument trays) due to reports of dislocations of the poly insert and the stem.
Z-0699-2017December 14, 2016Bloomington, MN
Encore Medical, Lp
Class IITerminated
Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedur...
Reason: A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus.
Z-0711-2017December 14, 2016Austin, TX
Sorin Group USA, Inc.
Class IITerminated
The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement...
Reason: Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS Programmer because the residual longevity estimate may be less accurate.
Z-0412-2017November 23, 2016Arvada, CO
Sorin Group USA, Inc.
Class IITerminated
The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measur...
Reason: Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS Programmer because the residual longevity estimate may be less accurate.
Z-0413-2017November 23, 2016Arvada, CO
Encore Medical, Lp
Class IITerminated
Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
Reason: It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. The current design ...
Z-0325-2017November 9, 2016Austin, TX
St Jude Medical Inc.
Class ITerminated
Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241-40, CD1241-40Q. Fortify Assura VR, Model No. CD1257-40, CD1257-40Q, CD1357-40C. Fortify Assura ST VR, Model No. CD1263-4...
Reason: St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature batte...