NuVasive Specialized Orthopedics, Inc.: Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 10.0

Hazard

Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.

Details from the source

Reason for recall: Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices. Distribution: U.S distribution to states of: FL and NV. Quantity: 164 devices Lot/code info: Part Number: PM10.0-80B265 UDI codes: (01)00195377150929(11)240223(17)290131(10)4021504AAA (01)00195377150929(11)240301(17)290228(10)4022214AAA Lot Numbers: 4021504AAA 4022214AAA Part Number: PM10.0-80B280 UDI codes: (01)00195377151032(11)240222(17)290131(10)4021505AAA (01)00195377151032(11)240220(17)290131(10)4021903AAA Lot Numbers: 4021505AAA 4021903AAA Part Number: PM10.0-80B305 UDI Codes: (01)00195377151148(11)240214(17)290131(10)4021217AAA (01)00195377151148(11)240220(17)290131(10)4021901AAA (01)00195377151148(11)240304(17)290228(10)4022131AAA Lot Numbers: 4021217AAA 4021901AAA 4022131AAA PM10.0-80B335 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 335mm 4021218AAA (01)00195377151254(11)240215(17)290131(10)4021218AAA 4021910AAA (01)00195377151254(11)240221(17)290131(10)4021910AAA 4022301AAA (01)00195377151254(11)240304(17)290228(10)4022301AAA 4022625AAA (01)00195377151254(11)240301(17)290228(10)4022625AAA PM10.0-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 365mm 4022135AAA (01)00195377151360(11)240304(17)290228(10)4022135AAA 4022136AAA (01)00195377151360(11)240223(17)290131(10)4022136AAA PM10.0-80TJ265 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 265mm 4021307AAA (01)00195377150998(11)240219(17)290131(10)4021307AAA 4021926AAA (01)00195377150998(11)240221(17)290131(10)4021926AAA PM10.0-80TJ280 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 280mm 4021314AAA (01)00195377151100(11)240215(17)290131(10)4021314AAA 4021602AAA (01)001953

UPC codes

00195377150929, 00195377151032, 00195377151148, 00195377151254, 00195377151360, 00195377150998, 00195377151100, 00195377151216, 00195377151698, 00195377151803, 00195377151919, 00195377152022, 00195377152138, 00195377151766, 00195377151872, 00195377151988, 00195377152572, 00195377152688, 00195377152909

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.