Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 48 of 125
Flowonix Medical Inc
Class II Ongoing
US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 00810335020082
Reason: A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm ton...
Z-1123-2020 February 19, 2020 Mansfield, MA
Microvention, Inc.
Class II Terminated
Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45-751019, 45-751324, 45-751632, 45-752039, 45-750407, 45-750511, 45-750617, 45-750609, 45-750812, 45-750824, MV-AX50407CD, M...
Reason: The devices may be missing the implant coil.
Z-1225-2020 February 19, 2020 Aliso Viejo, CA
Implant Direct Sybron Manufacturing LLC
Class II Terminated
SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
Reason: Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were c...
Z-1126-2020 February 19, 2020 Westlake Village, CA
Flowonix Medical Inc
Class II Ongoing
Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific)
Reason: A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm ton...
Z-1125-2020 February 19, 2020 Mansfield, MA
Flowonix Medical Inc
Class II Ongoing
Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
Reason: A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm ton...
Z-1122-2020 February 19, 2020 Mansfield, MA
Microvention, Inc.
Class II Terminated
Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and 45-680820, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA;...
Reason: The devices may be missing the implant coil.
Z-1221-2020 February 19, 2020 Aliso Viejo, CA
Microvention, Inc.
Class II Terminated
Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System, REF numbers 45-481015, 45-481020, 45-481215, 45-481220, 45-481515, 45-481520, 45-482020, 45-482030, 45-480202,...
Reason: The devices may be missing the implant coil.
Z-1220-2020 February 19, 2020 Aliso Viejo, CA
Flowonix Medical Inc
Class II Ongoing
Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country language specific)
Reason: A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm ton...
Z-1124-2020 February 19, 2020 Mansfield, MA
Flowonix Medical Inc
Class II Ongoing
Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
Reason: A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm ton...
Z-1121-2020 February 19, 2020 Mansfield, MA
Microvention, Inc.
Class II Terminated
Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032, 45-781238, 45-781434, 45-781639, 45-781836, 45-782040, 45-780202, 45-780204, 45-780304, 45-780308, 45-780413, 45-7...
Reason: The devices may be missing the implant coil.
Z-1222-2020 February 19, 2020 Aliso Viejo, CA
Centurion Medical Products Corporation
Class II Terminated
Centurion- Dressing Change Kits DYNDC1182B PICC INSERTION TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1586C CENTRAL LINE DRESSING NGE TRAY DYNDC1597A CVC DRESSING CHANGE T...
Reason: Incomplete seals on the sterile package may compromise the sterility
Z-1049-2020 February 12, 2020 Williamston, MI
Implant Direct Sybron Manufacturing LLC
Class II Terminated
Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
Reason: Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.
Z-1041-2020 February 12, 2020 Westlake Village, CA
Centurion Medical Products Corporation
Class II Terminated
Centurion-Suture Trays SUT10140 SUTURE TRAY SUT10290 LACERATION TRAY SUT10705 SUTURING TRAY SUT10770 DEBRIDEMENT/SUTURE SET SUT10795 PORT IMPLANT SET SUT11035 SUTURE TRAY SUT11065 LACERATION TR...
Reason: Incomplete seals on the sterile package may compromise the sterility
Z-1057-2020 February 12, 2020 Williamston, MI
Collagen Matrix Inc
Class II Terminated
GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants p...
Reason: The products may have been packaged with an incorrect Instructions for Use.
Z-0907-2020 February 5, 2020 Oakland, NJ
Collagen Matrix Inc
Class II Terminated
GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants p...
Reason: The products may have been packaged with an incorrect Instructions for Use.
Z-0909-2020 February 5, 2020 Oakland, NJ
Collagen Matrix Inc
Class II Terminated
GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 - - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around imp...
Reason: The products may have been packaged with an incorrect Instructions for Use.
Z-0910-2020 February 5, 2020 Oakland, NJ
Collagen Matrix Inc
Class II Terminated
GIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around impla...
Reason: The products may have been packaged with an incorrect Instructions for Use.
Z-0912-2020 February 5, 2020 Oakland, NJ
Exactech, Inc.
Class II Terminated
Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF 304-22-11 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally mature individuals with d...
Reason: Labels with incorrect translations were identified by Exactech is a distributor in the Netherlands. The translations on the outer labels include the word " long" in all languages...
Z-0873-2020 February 5, 2020 Gainesville, FL
Exactech, Inc.
Class II Terminated
Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally mature individuals with de...
Reason: Labels with incorrect translations were identified by Exactech is a distributor in the Netherlands. The translations on the outer labels include the word " long" in all languages...
Z-0872-2020 February 5, 2020 Gainesville, FL
Collagen Matrix Inc
Class II Terminated
GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around impla...
Reason: The products may have been packaged with an incorrect Instructions for Use.
Z-0911-2020 February 5, 2020 Oakland, NJ
Collagen Matrix Inc
Class II Terminated
GIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants p...
Reason: The products may have been packaged with an incorrect Instructions for Use.
Z-0908-2020 February 5, 2020 Oakland, NJ
Paltop Advanced Dental Solutions Ltd
Class II Terminated
Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020
Reason: Some of the implants were packaged with a Standard Platform Cover Screw instead of a Narrow Platform Cover Screw. The Standard Platform Cover Screw will not fit in the Narrow Plat...
Z-0836-2020 January 29, 2020 Caesarea
Trilliant Surgical, LLC
Class II Terminated
Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
Reason: A screwdriver used to facilitate implant insertion and removal was found to be out of specification for the minor diameter of the drive feature causing the driver to be unable to r...
Z-0799-2020 January 22, 2020 Houston, TX
Howmedica Osteonics Corp.
Class II Terminated
Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #: 2041C-3254
Reason: May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire
Z-0811-2020 January 22, 2020 Mahwah, NJ
Implant Direct Sybron Manufacturing, LLC
Class II Completed
ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Reason: The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion.
Z-0791-2020 January 15, 2020 Thousand Oaks, CA