Precice Max recall
Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Femur Piriformis…
Why was Precice Max recalled?
Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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)00195377151100(11)240223(17)290131(10)4021602AAA 4022005AAA (01)00195377151100(11)240222(17)290131(10)4022005AAA PM10.0-80TJ305 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 305mm 4021401AAA (01)00195377151216(11)240229(17)290131(10)4021401AAA PM11.5-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 265mm 4021524AAA (01)00195377151698(11)240219(17)290131(10)4021524AAA PM11.5-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 280mm 4021502AAA (01)00195377151803(11)240216(17)290131(10)4021502AAA 4021503AAA (01)00195377151803(11)240216(17)290131(10)4021503AAA PM11.5-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 305mm 4021203AAA (01)00195377151919(11)240215(17)290131(10)4021203AAA 4021921AAA (01)00195377151919(11)240227(17)290131(10)4021921AAA 4022010AAA (01)00195377151919(11)240301(17)290228(10)4022010AAA PM11.5-80B335 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 335mm 4021205AAA (01)00195377152022(11)240216(17)290131(10)4021205AAA 4021530AAA (01)00195377152022(11)240219(17)290131(10)4021530AAA 4022011AAA (01)00195377152022(11)240228(17)290131(10)4022011AAA PM11.5-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 365mm 4021902AAA (01)00195377152138(11)240222(17)290131(10)4021902AAA PM11.5-80TJ265 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 265mm 4021404AAA (01)00195377151766(11)240221(17)290131(10)4021404AAA PM11.5-80TJ280 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 280mm 4021501AAA (01)00195377151872(11)240219(17)290131(10)4021501AAA 4022626AAA (01)00195377151872(11)240304(17)290228(10)4022626AAA PM11.5-80TJ305 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 305mm 4021407AAA (01)00195377151988(11)240216(17)290131(10)4021407AAA PM13.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 280mm 4021525AAA (01)00195377152572(11)240220(17)290131(10)4021525AAA 4022009AAA (01)00195377152572(11)240221(17)290131(10)4022009AAA PM13.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 305mm 4022623AAA (01)00195377152688(11)240301(17)290228(10)4022623AAA PM13.0-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 365mm 4022001AAA (01)00195377152909(11)240221(17)290131(10)4022001AAA
- Product
- Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Femur Piriformis…
- Recalling firm
- NuVasive Specialized Orthopedics, Inc.
- Quantity
- 164 devices
- Distribution
- U.S distribution to states of: FL and NV.
- Recall date
- November 27, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)