Class I - Dangerous
The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and could result in incorrect insertion of the device during surgery.
🦴
Implants & Prosthetics
🏥 Medical Devices • 4,540 recalls
Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly.
Cleaning process validation failure.
Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance when these wires are crossed is that when a low SpO2 value is measured, a high SpO2 value would be displayed on the monitoring device. Additionally when a high SpO2 value is measured, a low SpO2 value would be displayed on the monitoring device.
Class I - Dangerous
Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162.
Class I - Dangerous
TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be associated with rapid emptying of the fill polymer syringe when it is connected to the Autoinjector during the fill polymer injection step of the primary implant procedure.
Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)
Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.
Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.
Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced an increased rate of premature battery depletion due to compromised performance of a low voltage (LV) capacitor. Boston Scientific updated their August 2013 Physician communication to include additional devices that may experience premature battery depletion due to compromised performance of a low volt
Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.
Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)
Class I - Dangerous
The affected products are missing polar boss threads.
Class I - Dangerous
Incorrect dimension on four liners was detected
Class I - Dangerous
Packaging of a device was compromised
An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial.
MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.
Orthohelix Surgical Designs
Class I - Dangerous
Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer
The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouch and packaged in a cardboard shipping carton with ten pouches in each shipping carton.
Richard Wolf Medical Instruments
Class I - Dangerous
Richard Wolf Medical Instrument Corporation is recalling Hulka Clip Tubal Occluding Device lot 51000232. The devices are being recalled as a part of an investigation into a biocompatibility test discrepancy where the recalled lot (lot 51000232) passed final release testing, but the subsequent lot failed biocompatibility testing on a component that was also used to manufacture lot 51000232.
Class I - Dangerous
Investigation determined that units supplied were missing the 4x21 degree helix angle.
Class I - Dangerous
The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cortical bone, and corresponding stripping of the 2.5mm Persona Hex Driver.