Class I - Dangerous
Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.
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Implants & Prosthetics
🏥 Medical Devices • 4,589 recalls
Class I - Dangerous
Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.
Class I - Dangerous
Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.
Class I - Dangerous
Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.
Class I - Dangerous
The bearings of the saw attachments were ungreased.
2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)
Mako Surgical
Class I - Dangerous
The bearings of the saw attachments were ungreased.
Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
Conformis
Class I - Dangerous
Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.
Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
Conformis
Class I - Dangerous
Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.
The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use.
Class I - Dangerous
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
Class I - Dangerous
The titanium implant has the wrong article number laser marked on it.
Class I - Dangerous
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
Class I - Dangerous
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
Class I - Dangerous
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
Class I - Dangerous
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
Class I - Dangerous
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
There is the potential that a HeatWrap could include cells that have a higher cell temperature than specified in lot S97473. The use of heat cell wrap with increased temperatures poses a potential risk of skin injuries such as burns/blisters and/or skin irritation on the wrap-applied area.
Foreign Material in the Alvarado Knee Holder Base Plate Assembly and Foot Piece and Alvarado II Base Plate and Foot Piece due to potentially inadequate cleaning procedures
There is the potential that a HeatWrap could include cells that have a higher cell temperature than specified in lot S97473. The use of heat cell wrap with increased temperatures poses a potential risk of skin injuries such as burns/blisters and/or skin irritation on the wrap-applied area.
Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.