Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 49–60 of 71 recalls
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture.…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture.…
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle.…
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle.…
There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.
Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.