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.
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Implants & Prosthetics
ðĨ Medical Devices âĒ 4,540 recalls
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.
Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1
Busse Hospital Disposables
Class I - Dangerous
Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable
Class I - Dangerous
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery convenience kit
ROi CPS
Class I - Dangerous
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Class I - Dangerous
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Class I - Dangerous
The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
Class I - Dangerous
Laser System may detect Error 106 or Error 108 System Failures that will cause the system to enter non-recoverable safe state. The user will not be able to proceed until the error is cleared. May result in initiation of treatment delay and/or treatment beyond initial scope and/or unable to treat patient.
Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in various types of orthopedic surgery (i.e. foot, ankle, hand, knee, hip or spine surgery). Catalog#: 376780
Beaver Visitec International
Class I - Dangerous
Incorrect configuration of the blades in the package. The blades curve to the right instead of curving to the left. If used may cause cause unintended tissue damage during the procedure or if noticed prior to use may cause a delay in surgery
Class I - Dangerous
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Class I - Dangerous
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.