GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07
DeRoyal Industries
Class I - Dangerous
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
ðĶī
Implants & Prosthetics
ðĨ Medical Devices âĒ 4,589 recalls
DeRoyal ANTERIOR APPROACH TOTAL HIP A&B PGYBK, REF 89-10612.01
DeRoyal Industries
Class I - Dangerous
XXX
DeRoyal TOTAL KNEE PACK A & B PACK, REF 89-6799.02
DeRoyal Industries
Class I - Dangerous
XXX
BASIC IMPLANT PACK, Item No. 40310SBI, oral surgery tray
Stradis Medical, LLC
Class I - Dangerous
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
HENRY SCHEIN, Knee Pack, Item No.570-2908,
Stradis Medical, LLC
Class I - Dangerous
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
GEO-MED TOTAL KNEE PACK A & B, REF 89-6799.02
DeRoyal Industries
Class I - Dangerous
XXX
DeRoyal CANNULTED HIP PACK CSM, REF 89-6977.09
DeRoyal Industries
Class I - Dangerous
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
STRADIS HEALTHCARE, Implants, Item No.41015NSI, dental tray
Stradis Medical, LLC
Class I - Dangerous
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
DeRoyal PACEMAKER ICD PACK, REF 89-10216.06
DeRoyal Industries
Class I - Dangerous
XXX
GEO-MED SHOULDER ARTHROSCOPY KNEE PACK, REF 89-5797.09
DeRoyal Industries
Class I - Dangerous
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
DeRoyal TOTAL HIP KIT, REF 89-9498.10
DeRoyal Industries
Class I - Dangerous
XXX
DeRoyal TOTAL HIP PACK, REF 89-9301.07
DeRoyal Industries
Class I - Dangerous
XXX
DeRoyal PACEMAKER ICD PACK, REF 89-10216.03
DeRoyal Industries
Class I - Dangerous
XXX
DeRoyal TOTAL HIP KIT, REF 89-9498.08
DeRoyal Industries
Class I - Dangerous
XXX
Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
Intersect ENT
Class I - Dangerous
Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.
Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
Class I - Dangerous
The devices may be packaged with the wrong reamer size.
Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
Potential for intraoperative screw head separation at weld location.
Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.