Class I - Dangerous
Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
Musculoskeletal Transplant Foundation
9 recalls • • Categories: Other Medical Devices, Infusion Pumps, Surgical Instruments
Class I - Dangerous
Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
Class I - Dangerous
Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery.
3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery
Class I - Dangerous
Measurement listed on the label is not taken under tension, and this would cause possible extension of surgical time needed to complete the procedure.
AFT Diverted Tubes are being recalled due to a customer complaint involving one unit which had an unsealed Tyvek pouch. The non-sterile foil pouch may introduce contamination into the sterile field.
Class I - Dangerous
Musculoskeletal Transplant Foundation (MTF) is recalling one lot of MTF's Allograft Cortical Pins because the lot was labeled as a 2.0 mm diameter pin and it may contain a 2.4 mm diameter pin.
Musculoskeletal Transplant Foundation is recalling a certain lot of Allofix Insertion Kits because they are labeled as having a 2.0mm diameter drill however it may contain a 2.4 mm diameter drill.
Class I - Dangerous
The seal on the DBX Mix outer PETG/Aclar tray with foil lid packaging for lot identified above may not be fully intact.