Implants & Prosthetics

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.

Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use.

Events related to a pacing rate outside of the intended setting, including events of sudden increased pacing rate up to the maximum setting of 180 pulses per minute (ppm), have been reported. This is caused by the development of high resistance on internal electrical connector contacts due to oxidation over time.

During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.

During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.

Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unusually, that battery should no longer be used and should be replaced.

During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.

A femoral component containing pegs was found in a box for the pegless version.

This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads are missing from the stem, the likelihood of the set screw loosening from the radial stem intraoperatively is increased. If the set screw loosens, a revision surgery may be necessary.

Some refill kits in the affected lots may contain an extension tubing set that is occluded and healthcare professionals may be unable to aspirate or fill the SynchroMed pumps. There is no problem with the Lioresal Intrathecal (baclofen injection) contained in the affected drug refill kits. There have been no patient injuries beyond additional needle sticks associated with this issue.

Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

This recall provides important new information regarding overinfusion associated with the Medtronic SynchroMed II Implantable Pump. Overinfusion can result in a life-threatening overdose and can also result in drug withdrawal due to premature emptying of the pump. Due to the low reported rate of occurrence of this issue and the inability to predict which pumps may be at risk, Medtronic is not re

It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the sterile field: Impact Cap: The impact cap on the Lock Shaft Inserter can shear off under high-impact force during insertion and removal. Pin: The pin used to guide the Lock Shaft Inserter into the ma

Manufacturing of these devices with a grade of stainless steel that is not within specifications.

The outer package label contained the incorrect length of the device. There is a label on the outer package and an additional label on the product contained in the package.

The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector.

The shell was missing the locking ring.