HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect calcium results when using the ABX PENTRA CALCIUM CP reagent.
🦴
Implants & Prosthetics
🏥 Medical Devices • 4,589 recalls
Smiths Medical is conducting a voluntary recall of PORT-A-CATH¿ and PORT-A-CATH¿ II Implantable Venous and Arterial Access Systems and Introducer Sets. Smiths Medical has become aware of a small number of customer reports regarding the introducer sheath and the introducer opening being too small for the width of the catheter with the use of these Sets. Smiths Medical has received no reports
Smiths Medical is conducting a voluntary recall of PORT-A-CATH¿ and PORT-A-CATH¿ II Implantable Venous and Arterial Access Systems and Introducer Sets. Smiths Medical has become aware of a small number of customer reports regarding the introducer sheath and the introducer opening being too small for the width of the catheter with the use of these Sets. Smiths Medical has received no reports
When positioning the display located on top of the video cart, it is possible for the user to apply excessive force and push the display up and out of the mounting arm. This can result in the display falling upon the user/patient.
This recall is being initiated in response to complaints received where it was reported that the proximal end of the Slap Hammer broke during use.
Product not cleared for sale/use in the United States.
Product not cleared for sale/use in the United States.
Following the identification of the disassociation of an impactor tip during surgery, Tornier is initiating a voluntary recall of all lots of Aequalis Reversed II and Reversed Fracture impactors. Upon review of the event, Tornier determined that a redesign of the instrument was warranted. These products are contained within the Aequalis Revered II instrument set tray no YKAD83 and the Aequalis R
Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.
Synthes USA HQ
Class I - Dangerous
Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed.
One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.
Class I - Dangerous
One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8 Removal head failing during removal of the CD Horizon Spire and Spire Z Spinal System implant. There is a potential for tissue damage to occur and/or minor surgical delay to remove the remaining fragments of the tip.
Product not cleared for sale/use in the United States.
Product not cleared for sale/use in the United States.
Class I - Dangerous
The product has the potential to be laser marked as a Medium when it actually is a Small.
One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.
Class I - Dangerous
A component Superior endplate manufactured from a different polymer than specified
A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility
Siemens confirmed that the ADVIA¿ Chemistry Systems HbA1c method exhibits a positive bias of up to 12% for patient and CAP survey samples due to over-recovery when using A1c_3 Calibrator lots 1MD014, 1BD063, and 2GD014. The established ranges of CAP Survey Samples GH2-04, GH2-05 and GH2-06 and IFCC sample recoveries use ¿ 7% from the established mean as their acceptance criteria. This is the criterion that was used during testing to confirm the customer complaints. Depending upon quality control limits this issue may not have been detected..
A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility
Class I - Dangerous
The firm became aware of an incident relating to a breach of sterility in the sterility barrier packaging of SC2316, Distal Femoral Augment with Screw.