A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Polymer leaks may occur during implantation of abdominal stent graft system. Clinical events related to polymer leaks may be systemic and/or aneurysm related.

May 6, 2020 Implants & Prosthetics Nationwide View Details →

smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 71338733 50MM 71338734 52MM 71338735 54MM 71338736 56MM 71338737 58MM 71338738 62MM 71338740 64MM 71338741 Orthopedic implant component.

Smith & Nephew

Class I - Dangerous

A manufacturing error resulted in out of specification R3 Acetabular Shells

Apr 22, 2020 Implants & Prosthetics View Details →

smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540 42MM 71335542 44MM 71335544 46MM 71335546 48MM 71335548 50MM 71335550 52MM 71335552 54MM 71335554 56MM 71335556 58MM 71335558 60MM 71335560 Orthopedic implant component.

Smith & Nephew

Class I - Dangerous

A manufacturing error resulted in out of specification R3 Acetabular Shells

Apr 22, 2020 Implants & Prosthetics View Details →

Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM, Item Number 810M5535 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicated for skeletally mature patients and for adolescence patients.

Zimmer Biomet

Class I - Dangerous

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

May 5, 2020 Implants & Prosthetics Nationwide View Details →

Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X45MM, Item Number 810M4545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicated for skeletally mature patients and for adolescence patients.

Zimmer Biomet

Class I - Dangerous

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

May 5, 2020 Implants & Prosthetics Nationwide View Details →

Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM, Item Number 811M8555 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicated for skeletally mature patients and for adolescence patients.

Zimmer Biomet

Class I - Dangerous

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

May 5, 2020 Implants & Prosthetics Nationwide View Details →

Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM, Item Number 810M5550 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicated for skeletally mature patients and for adolescence patients.

Zimmer Biomet

Class I - Dangerous

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

May 5, 2020 Implants & Prosthetics Nationwide View Details →

Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X45MM, Item Number 810M5545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicated for skeletally mature patients and for adolescence patients.

Zimmer Biomet

Class I - Dangerous

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

May 5, 2020 Implants & Prosthetics Nationwide View Details →

Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X60MM, Item Number 811M8560 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicated for skeletally mature patients and for adolescence patients.

Zimmer Biomet

Class I - Dangerous

There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

May 5, 2020 Implants & Prosthetics Nationwide View Details →

Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001

Medtronic

Class I - Dangerous

Internal testing results showed endotoxin-related test result did not meet specifications for implantable insulin pump. If pumps have higher than allowed endotoxin levels, patients may have an effect of fever, hypotension, anaphylactic shock, hyperglycemia, or diabetic ketoacidosis (DKA), potentially followed by secondary multi-organ failure (primarily renal and hepatic) and/or death.

Apr 10, 2020 Implants & Prosthetics View Details →

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