Overview of recall records associated with Integra LifeSciences Corp., including dates, categories and classifications where available.
Classification mix: Class II: 163, Class I: 5, Class III: 1.
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
Incorrect gel part number listed in a master manufacturing record
Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral stem trial whiling preparing…
A faulty footswitch may result in unintended ultrasonic fragmentation activation. There are two scenarios when the failure mode may occur: 1) Ultrasonic fragmentation may be inadvertently…
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Data from internal studies suggests there may be a potential that the secondary package seal integrity does not provide the level of sterility intended for Minimally Invasive Achilles…
Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw".
Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical…
Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical…
The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.
As a result of an internal review of all labeling for the Cadence System, it was determined that the outer package label for the Size 5 Left Tibial Tray Implant reflects the material…
The affected K-wires do not meet specification requirements. Specifically, a) K-wires were made of 316LVM stainless steel instead of 304 stainless steel. b) K-wires have passivated surface…
As a result of an internal investigation of a non-conformance it has been determined: 1) Depth Gauges from Lot UP15H2 exceed the overall length specification requirements. 2) Depth Gauges…
Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.
Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.
Integra identified that the UCHRAP component (Arc Adapter Plate) would not assemble properly to the UCHRAR component (ARC Adapter Ring) of the Compact Head Ring Adapter due to an error in…
This page summarizes recall records in which the official source identifies Integra LifeSciences Corp. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
