Orthopaedic bone cement restrictor instrumentation. DePuy SmartSeal™ pressurisers- femoral and acetabular pressurisers (5 pack) manufactured by DePuy CMW.
DePuy SmartSeal™ pressuriser: femoral and acetabular pressurisers (5 pack) for use with orthopaedic bone cement.
Part numbers
3206045 – 45mm acetabular pressuriser
3206052 – 52mm acetabular pressuriser
3206055 – 55mm acetabular pressuriser
3206060 – 60mm acetabular pressuriser
3206065 – 65mm acetabular pressuriser
3206002 – wedge femoral pressuriser
3206005 – standard femoral pressuriser
Lot numbers - all lot numbers are affected by this recall.
Any DePuy SmartSeal pressurisers that have a black tick on the bottom right hand corner of the pouch and on the carton have already been re-inspected by DePuy CMW and the manufacturer has verified that the seals are fully intact. These products are now excluded from the recall.
Total hip replacement: DePuy Ultima TPS femoral stem used in combination with Ultima metal-on-metal articulation.
DePuy Ultima TPS femoral stem used in combination with Ultima metal-on-metal articulation. These components were only sold in combination in the UK, France and Italy.
All lots of the DePuy-Synthes Radial Head prosthesis system are affected.For part number and description information for the device and associated parts refer to Attachment 1 of the manufacturer’s Field Safety Notice and the spreadsheet attached to this alert, which includes both catalogue numbers and relevant UDI Device Identifier codes (GS1 GTINs).