Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 79 of 125
Biomet 3i, LLC
Class II Terminated
BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(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.
Z-0830-2017 December 28, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use ...
Reason: A limited number of product pouches may not have been sealed during packaging.
Z-0859-2017 December 28, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
BIOMET 3i LOW PROFILE ABUTMENT HEXED TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is in...
Reason: A limited number of product pouches may not have been sealed during packaging.
Z-0860-2017 December 28, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(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.
Z-0843-2017 December 28, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 5MM(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.
Z-0834-2017 December 28, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
BIOMET 3i CERTAIN 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 ...
Reason: A limited number of product pouches may not have been sealed during packaging.
Z-0839-2017 December 28, 2016 Palm Beach Gardens, FL
Stanmore Implants Worldwide Ltd.
Class II Terminated
Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short The product is a component is a system...
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-0821-2017 December 28, 2016 Borehamwood, N/A
Synthes (USA) Products LLC
Class II Terminated
Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument
Reason: The screw rack plate was assembled incorrectly which could cause the screws in the screw rack to sit low and touch the surface beneath the screw rack.
Z-0867-2017 December 28, 2016 West Chester, PA
Biomet 3i, LLC
Class II Terminated
BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(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.
Z-0833-2017 December 28, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
BIOMET 3i 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 intended fo...
Reason: A limited number of product pouches may not have been sealed during packaging.
Z-0849-2017 December 28, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
BIOMET 3i LOW PROFILE ABUTMENT (HEXED) PICK-UP IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant an...
Reason: A limited number of product pouches may not have been sealed during packaging.
Z-0856-2017 December 28, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
BIOMET 3i 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 is inten...
Reason: A limited number of product pouches may not have been sealed during packaging.
Z-0847-2017 December 28, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(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.
Z-0848-2017 December 28, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
BIOMET 3i CERTAIN 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 ...
Reason: A limited number of product pouches may not have been sealed during packaging.
Z-0842-2017 December 28, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) TRANSFER IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental imp...
Reason: A limited number of product pouches may not have been sealed during packaging.
Z-0862-2017 December 28, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
BIOMET 3i LOW PROFILE ABUTMENT HEALING CAP An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use ...
Reason: A limited number of product pouches may not have been sealed during packaging.
Z-0855-2017 December 28, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER 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.
Z-0861-2017 December 28, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
BIOMET 3i 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 is intend...
Reason: A limited number of product pouches may not have been sealed during packaging.
Z-0846-2017 December 28, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
BIOMET 3i CERTAIN LOW PROFILE 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 int...
Reason: A limited number of product pouches may not have been sealed during packaging.
Z-0840-2017 December 28, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(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.
Z-0845-2017 December 28, 2016 Palm Beach Gardens, FL
Stanmore Implants Worldwide Ltd.
Class II Terminated
DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF Coated Integral Shaft & Stem 30x36x44 The product is a c...
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-0824-2017 December 28, 2016 Borehamwood, N/A
Biomet 3i, LLC
Class II Terminated
BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) PICK-UP IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental impl...
Reason: A limited number of product pouches may not have been sealed during packaging.
Z-0857-2017 December 28, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
BIOMET 3i CERTAIN 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 ...
Reason: A limited number of product pouches may not have been sealed during packaging.
Z-0841-2017 December 28, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
BIOMET 3i CERTAIN LOW PROFILE 17¿ 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 i...
Reason: A limited number of product pouches may not have been sealed during packaging.
Z-0828-2017 December 28, 2016 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(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.
Z-0854-2017 December 28, 2016 Palm Beach Gardens, FL