Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months
Integra Limited
9 recalls • • Categories: Surgical Instruments, Implants & Prosthetics, Diagnostic Equipment, Infusion Pumps
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
Integra LifeSciences has identified through an internal evaluation that in order to comply with US FDA requirements, certain Camino¿ Intracranial Pressure Monitoring Kits require additional labelling to indicate they are UNSAFE in an MR environment. Only the following Camino¿ Intracranial Pressure Monitoring Kits are affected: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC.
As a result of complaint investigations it was identified that there is a potential that the Leyla Ball Joint Clamp (R2383) may not provide the level of stability needed to maintain retraction in all cases.
An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel Pads were packaged as a Right Horseshoe Gel Pads and vice versa. None of the complaints resulted in a report of patient injuries or an increase in the time to complete the surgical procedure. A physician was consulted to assess patient risk and concluded that there is no potential harm to patients, onl
An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel Pads were packaged as a Right Horseshoe Gel Pads and vice versa. None of the complaints resulted in a report of patient injuries or an increase in the time to complete the surgical procedure. A physician was consulted to assess patient risk and concluded that there is no potential harm to patients, onl
The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification.