Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL NTRL LNR G332MM 140-32-54 NV EHXLNTRL LNR G4 32MM 140-32-55 NV EHXLNTRL LNR G5 32MM 140-36-52 NV EHXLNTRL LNR G2 36MM 140-36-53 NV EHXL NTRL LNR G336MM 140-36-54 NV EHXLNTRL LNR G4 36MM 140-36-55 NV EHXLNTRL LNR G5 36MM 140-40-53 NV EHXLNTRL LNR G3 40MM 140-40-54 NV EHXLNTRL LNR G4 40MM 140-40-55 NV EHXLNTRL LNR G5 40MM 142-22-68 NV EHXL ALPLNR G00 22MM 142-22-70 NV EHXL LIPLNR G00 22MM 142-28-50 NV EHXL LIP LNR G0 28MM 142-28-51 NV EHXL LIP LNR G1 28MM 142-28-52 NV EHXL LIP LNR G2 28MM 142-28-60 NV EHXL ALIPLNR G0 28MM 142-28-61 NV EHXL ALIP LNR G1 28MM 142-28-62 NV EHXL ALIP LNR G2 28MM 142-32-51 NV EHXL LIP LNR G1 32MM 142-32-52 NV EHXL LIP LNR G2 32MM 142-32-53 NV EHXL LIP LNR G3 32MM 142-32-54 NV EHXL LIP LNR G4 32MM 142-32-55 NV EHXL LIP LNR G5 32MM 142-32-61 NV EHXL ALIP LNR G1 32MM 142-32-62 NV EHXL ALIP LNR G2 32MM 142-32-63 NV EHXL ALIP LNR G3 32MM 142-32-64 NV EHXL ALIP LNR G4 32MM 142-32-65 NV EHXL ALIP LNR G5 32MM 142-36-52 NV EHXL LIP LNR G2 36MM 142-36-53 NV EHXL LIP LNR G3 36MM 142-36-54 NV EHXL LIP LNR G4 36MM 142-36-55 NV EHXL LIP LNR G5 36MM 142-36-62 NV EHXL ALIP LNR G2 36MM 142-36-63 NV EHXL ALIP LNR G3 36MM 142-36-64 NV EHXL ALIP LNR G4 36MM 142-36-65 NV EHXL ALIP LNR G5 36MM 142-40-53 NV EHXL LIP LNR G3 40MM 142-40-54 NV EHXL LIP LNR G4 40MM 142-40-55 NV EHXL LIP LNR G5 40MM 142-40-63 NV EHXL ALIP LNR G3 40MM 142-40-64 NV EHXL ALIP LNR G4 40MM 142-40-65 NV EHXL ALIP LNR G5 40MM 146-22-70 NV EHXL LATLNR G00 22MM 146-28-51 NV EHXL LAT LNR G1 28MM 146-32-51 NV EHXL LAT LNR G1 32MM 146-32-52 NV EHXL LAT LNR G2 32MM 146-32-53 NV EHXL LAT LNR G3 32MM 146-32-54 NV EHXL LAT LNR G4 32MM 146-32-55 NV EHXL LAT LNR G5 32MM 146-36-52 NV EHXL LAT LNR G2 36MM 146-36-53 NV EHXL LAT LNR G3 36MM 146-36-54 NV EHXL LAT LNR G4 36MM 146-36-55 NV EHXL LAT LNR G5 36MM 146-40-53 NV EHXL LAT LNR G3 40MM 146-40-54 NV EHXL LAT LNR G4 40MM 146-40-55 NV EHXL LAT LNR G5 40MM 148-32-51 NV EHXL 10¿ LNR G1 32MM 148-36-52 NV EHXL 10¿ LNR G2 36MM 148-36-53 NV EHXL 10¿ LNR G3 36MM 148-36-54 NV EHXL 10¿ LNR G4 36MM 148-36-55 NV EHXL 10¿ LNR G5 36MM 148-40-53 NV EHXL 10¿ LNR G3 40MM 148-40-54 NV EHXL 10¿ LNR G4 40MM 148-40-55 NV EHXL 10¿ LNR G5 40MM All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment.

Class I - Dangerous

🏥 Medical Devices Recalled: December 31, 2024 Exactech Implants & Prosthetics Nationwide

What Should You Do?

Check if you have this product:
Item Number / Product Description/ UDI-DI code: 140-22-70 NV EHXL NTL LNR G00 22MM 10885862537225 140-28-50 NV EHXLNTRL LNR G0 28MM 10885862537232 140-28-51 NV EHXLNTRL LNR G1 28MM 10885862537249 140-28-52 NV EHXL NTRL LNR G228MM 10885862537256 140-32-51 NV EHXL NTRL LNR G132MM 10885862537263 Serial Numbers: 6594943 6970850 6595376 6595380 6858220 6858230 6973123 6594924 6970840 6595383 6595385 6595381 6970835 6970838 6970842 6595922 6510276 6973139 140-32-52 NV EHXL NTRL LNR G232MM 10885862537270 140-32-53 NV EHXL NTRL LNR G332MM 10885862537287 140-32-54 NV EHXLNTRL LNR G4 32MM 10885862537294 140-32-55 NV EHXLNTRL LNR G5 32MM 10885862537300 140-36-52 NV EHXLNTRL LNR G2 36MM 10885862537317 Serial Numbers: 6558356 6422337 6631675 6504196 6631677 6631695 6631712 6844304 6631689 6631699 6631725 6558360 6844285 6844298 6844281 6348961 6504177 6504195 6504202 6504204 6631686 6844321 140-36-53 NV EHXL NTRL LNR G336MM 10885862537324 Serial Numbers: 6600076 6600101 6600054 6600057 6600093 140-36-54 NV EHXLNTRL LNR G4 36MM 10885862537331 140-36-55 NV EHXLNTRL LNR G5 36MM 10885862537348 140-40-53 NV EHXLNTRL LNR G3 40MM 10885862537355 Serial Numbers: 6510314 6510327 140-40-54 NV EHXLNTRL LNR G4 40MM 10885862537362 140-40-55 NV EHXLNTRL LNR G5 40MM 10885862537379 142-22-68 NV EHXL ALPLNR G00 22MM 10885862537546 142-22-70 NV EHXL LIPLNR G00 22MM 10885862537386 142-28-50 NV EHXL LIP LNR G0 28MM 10885862537393 142-28-51 NV EHXL LIP LNR G1 28MM 10885862537409 142-28-52 NV EHXL LIP LNR G2 28MM 10885862537416 142-28-60 NV EHXL ALIPLNR G0 28MM 10885862537553 142-28-61 NV EHXL ALIP LNR G1 28MM 10885862537560 142-28-62 NV EHXL ALIP LNR G2 28MM 10885862537577 142-32-51 NV EHXL LIP LNR G1 32MM 10885862537423 142-32-52 NV EHXL LIP LNR G2 32MM 10885862537430 142-32-53 NV EHXL LIP LNR G3 32MM 10885862537447 142-32-54 NV EHXL LIP LNR G4 32MM 10885862537454 142-32-55 NV EHXL LIP LNR G5 32MM 10885862537461 142-32-61 NV EHXL ALIP LNR G1 32MM 10885862537584 Serial Numbers: 7040076 6842549 6554448 6596005 6554464 6554458 6866177 6596019 6554457 6595993 6503270 142-32-62 NV EHXL ALIP LNR G2 32MM 10885862537591 142-32-63 NV EHXL ALIP LNR G3 32MM 10885862537607 142-32-64 NV EHXL ALIP LNR G4 32MM 10885862537614 142-32-65 NV EHXL ALIP LNR G5 32MM 10885862537621 142-36-52 NV EHXL LIP LNR G2 36MM 10885862537478 142-36-53 NV EHXL LIP LNR G3 36MM 10885862537485 142-36-54 NV EHXL LIP LNR G4 36MM 10885862537492 142-36-55 NV EHXL LIP LNR G5 36MM 10885862537508 142-36-62 NV EHXL ALIP LNR G2 36MM 10885862537638 Serial Numbers: 6831997 6679288 6831980 7032226 6679275 6831983 6335167 6832001 6555554 7032248 6679286 6679321 6831992 6927281 142-36-63 NV EHXL ALIP LNR G3 36MM 10885862537645 142-36-64 NV EHXL ALIP LNR G4 36MM 10885862537652 142-36-65 NV EHXL ALIP LNR G5 36MM 10885862537669 142-40-53 NV EHXL LIP LNR G3 40MM 10885862537515 142-40-54 NV EHXL LIP LNR G4 40MM 10885862537522 142-40-55 NV EHXL LIP LNR G5 40MM 10885862537539 142-40-63 NV EHXL ALIP LNR G3 40MM 10885862537676 Serial Numbers: 6452595 142-40-64 NV EHXL ALIP LNR G4 40MM 10885862537683 142-40-65 NV EHXL ALIP LNR G5 40MM 10885862537690 146-22-70 NV EHXL LATLNR G00 22MM 10885862537751 146-28-51 NV EHXL LAT LNR G1 28MM 10885862537768 146-32-51 NV EHXL LAT LNR G1 32MM 10885862537775 146-32-52 NV EHXL LAT LNR G2 32MM 10885862537782 146-32-53 NV EHXL LAT LNR G3 32MM 10885862537799 146-32-54 NV EHXL LAT LNR G4 32MM 10885862537805 146-32-55 NV EHXL LAT LNR G5 32MM 10885862537812 146-36-52 NV EHXL LAT LNR G2 36MM 10885862537829 146-36-53 NV EHXL LAT LNR G3 36MM 10885862537836 146-36-54 NV EHXL LAT LNR G4 36MM 10885862537843 146-36-55 NV EHXL LAT LNR G5 36MM 10885862537850 146-40-53 NV EHXL LAT LNR G3 40MM 10885862537867 Serial Numbers: 6602255 6602261 6602265 6602268 6602269 6602270 6602272 6602256 6602263 6602267 6602277 6602257 6602258 6602273 146-40-54 NV EHXL LAT LNR G4 40MM 10885862537874 146-40-55 NV EHXL LAT LNR G5 40MM 10885862537881 148-32-51 NV EHXL 10¿ LNR G1 32MM 10885862537898 148-36-52 NV EHXL 10¿ LNR G2 36MM 10885862537904 148-36-53 NV EHXL 10¿ LNR G3 36MM 10885862537911 148-36-54 NV EHXL 10¿ LNR G4 36MM 10885862537928 148-36-55 NV EHXL 10¿ LNR G5 36MM 10885862537935 148-40-53 NV EHXL 10¿ LNR G3 40MM 10885862537942 148-40-54 NV EHXL 10¿ LNR G4 40MM 10885862537959 148-40-55 NV EHXL 10¿ LNR G5 40MM 10885862537966
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Exactech, Inc.
Reason for Recall:: Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL NTRL LNR G332MM 140-32-54 NV EHXLNTRL LNR G4 32MM 140-32-55 NV EHXLNTRL LNR G5 32MM 140-36-52 NV EHXLNTRL LNR G2 36MM 140-36-53 NV EHXL NTRL LNR G336MM 140-36-54 NV EHXLNTRL LNR G4 36MM 140-36-55 NV EHXLNTRL LNR G5 36MM 140-40-53 NV EHXLNTRL LNR G3 40MM 140-40-54 NV EHXLNTRL LNR G4 40MM 140-40-55 NV EHXLNTRL LNR G5 40MM 142-22-68 NV EHXL ALPLNR G00 22MM 142-22-70 NV EHXL LIPLNR G00 22MM 142-28-50 NV EHXL LIP LNR G0 28MM 142-28-51 NV EHXL LIP LNR G1 28MM 142-28-52 NV EHXL LIP LNR G2 28MM 142-28-60 NV EHXL ALIPLNR G0 28MM 142-28-61 NV EHXL ALIP LNR G1 28MM 142-28-62 NV EHXL ALIP LNR G2 28MM 142-32-51 NV EHXL LIP LNR G1 32MM 142-32-52 NV EHXL LIP LNR G2 32MM 142-32-53 NV EHXL LIP LNR G3 32MM 142-32-54 NV EHXL LIP LNR G4 32MM 142-32-55 NV EHXL LIP LNR G5 32MM 142-32-61 NV EHXL ALIP LNR G1 32MM 142-32-62 NV EHXL ALIP LNR G2 32MM 142-32-63 NV EHXL ALIP LNR G3 32MM 142-32-64 NV EHXL ALIP LNR G4 32MM 142-32-65 NV EHXL ALIP LNR G5 32MM 142-36-52 NV EHXL LIP LNR G2 36MM 142-36-53 NV EHXL LIP LNR G3 36MM 142-36-54 NV EHXL LIP LNR G4 36MM 142-36-55 NV EHXL LIP LNR G5 36MM 142-36-62 NV EHXL ALIP LNR G2 36MM 142-36-63 NV EHXL ALIP LNR G3 36MM 142-36-64 NV EHXL ALIP LNR G4 36MM 142-36-65 NV EHXL ALIP LNR G5 36MM 142-40-53 NV EHXL LIP LNR G3 40MM 142-40-54 NV EHXL LIP LNR G4 40MM 142-40-55 NV EHXL LIP LNR G5 40MM 142-40-63 NV EHXL ALIP LNR G3 40MM 142-40-64 NV EHXL ALIP LNR G4 40MM 142-40-65 NV EHXL ALIP LNR G5 40MM 146-22-70 NV EHXL LATLNR G00 22MM 146-28-51 NV EHXL LAT LNR G1 28MM 146-32-51 NV EHXL LAT LNR G1 32MM 146-32-52 NV EHXL LAT LNR G2 32MM 146-32-53 NV EHXL LAT LNR G3 32MM 146-32-54 NV EHXL LAT LNR G4 32MM 146-32-55 NV EHXL LAT LNR G5 32MM 146-36-52 NV EHXL LAT LNR G2 36MM 146-36-53 NV EHXL LAT LNR G3 36MM 146-36-54 NV EHXL LAT LNR G4 36MM 146-36-55 NV EHXL LAT LNR G5 36MM 146-40-53 NV EHXL LAT LNR G3 40MM 146-40-54 NV EHXL LAT LNR G4 40MM 146-40-55 NV EHXL LAT LNR G5 40MM 148-32-51 NV EHXL 10¿ LNR G1 32MM 148-36-52 NV EHXL 10¿ LNR G2 36MM 148-36-53 NV EHXL 10¿ LNR G3 36MM 148-36-54 NV EHXL 10¿ LNR G4 36MM 148-36-55 NV EHXL 10¿ LNR G5 36MM 148-40-53 NV EHXL 10¿ LNR G3 40MM 148-40-54 NV EHXL 10¿ LNR G4 40MM 148-40-55 NV EHXL 10¿ LNR G5 40MM All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment.

Product Codes/Lot Numbers:

Item Number / Product Description/ UDI-DI code: 140-22-70 NV EHXL NTL LNR G00 22MM 10885862537225 140-28-50 NV EHXLNTRL LNR G0 28MM 10885862537232 140-28-51 NV EHXLNTRL LNR G1 28MM 10885862537249 140-28-52 NV EHXL NTRL LNR G228MM 10885862537256 140-32-51 NV EHXL NTRL LNR G132MM 10885862537263 Serial Numbers: 6594943 6970850 6595376 6595380 6858220 6858230 6973123 6594924 6970840 6595383 6595385 6595381 6970835 6970838 6970842 6595922 6510276 6973139 140-32-52 NV EHXL NTRL LNR G232MM 10885862537270 140-32-53 NV EHXL NTRL LNR G332MM 10885862537287 140-32-54 NV EHXLNTRL LNR G4 32MM 10885862537294 140-32-55 NV EHXLNTRL LNR G5 32MM 10885862537300 140-36-52 NV EHXLNTRL LNR G2 36MM 10885862537317 Serial Numbers: 6558356 6422337 6631675 6504196 6631677 6631695 6631712 6844304 6631689 6631699 6631725 6558360 6844285 6844298 6844281 6348961 6504177 6504195 6504202 6504204 6631686 6844321 140-36-53 NV EHXL NTRL LNR G336MM 10885862537324 Serial Numbers: 6600076 6600101 6600054 6600057 6600093 140-36-54 NV EHXLNTRL LNR G4 36MM 10885862537331 140-36-55 NV EHXLNTRL LNR G5 36MM 10885862537348 140-40-53 NV EHXLNTRL LNR G3 40MM 10885862537355 Serial Numbers: 6510314 6510327 140-40-54 NV EHXLNTRL LNR G4 40MM 10885862537362 140-40-55 NV EHXLNTRL LNR G5 40MM 10885862537379 142-22-68 NV EHXL ALPLNR G00 22MM 10885862537546 142-22-70 NV EHXL LIPLNR G00 22MM 10885862537386 142-28-50 NV EHXL LIP LNR G0 28MM 10885862537393 142-28-51 NV EHXL LIP LNR G1 28MM 10885862537409 142-28-52 NV EHXL LIP LNR G2 28MM 10885862537416 142-28-60 NV EHXL ALIPLNR G0 28MM 10885862537553 142-28-61 NV EHXL ALIP LNR G1 28MM 10885862537560 142-28-62 NV EHXL ALIP LNR G2 28MM 10885862537577 142-32-51 NV EHXL LIP LNR G1 32MM 10885862537423 142-32-52 NV EHXL LIP LNR G2 32MM 10885862537430 142-32-53 NV EHXL LIP LNR G3 32MM 10885862537447 142-32-54 NV EHXL LIP LNR G4 32MM 10885862537454 142-32-55 NV EHXL LIP LNR G5 32MM 10885862537461 142-32-61 NV EHXL ALIP LNR G1 32MM 10885862537584 Serial Numbers: 7040076 6842549 6554448 6596005 6554464 6554458 6866177 6596019 6554457 6595993 6503270 142-32-62 NV EHXL ALIP LNR G2 32MM 10885862537591 142-32-63 NV EHXL ALIP LNR G3 32MM 10885862537607 142-32-64 NV EHXL ALIP LNR G4 32MM 10885862537614 142-32-65 NV EHXL ALIP LNR G5 32MM 10885862537621 142-36-52 NV EHXL LIP LNR G2 36MM 10885862537478 142-36-53 NV EHXL LIP LNR G3 36MM 10885862537485 142-36-54 NV EHXL LIP LNR G4 36MM 10885862537492 142-36-55 NV EHXL LIP LNR G5 36MM 10885862537508 142-36-62 NV EHXL ALIP LNR G2 36MM 10885862537638 Serial Numbers: 6831997 6679288 6831980 7032226 6679275 6831983 6335167 6832001 6555554 7032248 6679286 6679321 6831992 6927281 142-36-63 NV EHXL ALIP LNR G3 36MM 10885862537645 142-36-64 NV EHXL ALIP LNR G4 36MM 10885862537652 142-36-65 NV EHXL ALIP LNR G5 36MM 10885862537669 142-40-53 NV EHXL LIP LNR G3 40MM 10885862537515 142-40-54 NV EHXL LIP LNR G4 40MM 10885862537522 142-40-55 NV EHXL LIP LNR G5 40MM 10885862537539 142-40-63 NV EHXL ALIP LNR G3 40MM 10885862537676 Serial Numbers: 6452595 142-40-64 NV EHXL ALIP LNR G4 40MM 10885862537683 142-40-65 NV EHXL ALIP LNR G5 40MM 10885862537690 146-22-70 NV EHXL LATLNR G00 22MM 10885862537751 146-28-51 NV EHXL LAT LNR G1 28MM 10885862537768 146-32-51 NV EHXL LAT LNR G1 32MM 10885862537775 146-32-52 NV EHXL LAT LNR G2 32MM 10885862537782 146-32-53 NV EHXL LAT LNR G3 32MM 10885862537799 146-32-54 NV EHXL LAT LNR G4 32MM 10885862537805 146-32-55 NV EHXL LAT LNR G5 32MM 10885862537812 146-36-52 NV EHXL LAT LNR G2 36MM 10885862537829 146-36-53 NV EHXL LAT LNR G3 36MM 10885862537836 146-36-54 NV EHXL LAT LNR G4 36MM 10885862537843 146-36-55 NV EHXL LAT LNR G5 36MM 10885862537850 146-40-53 NV EHXL LAT LNR G3 40MM 10885862537867 Serial Numbers: 6602255 6602261 6602265 6602268 6602269 6602270 6602272 6602256 6602263 6602267 6602277 6602257 6602258 6602273 146-40-54 NV EHXL LAT LNR G4 40MM 10885862537874 146-40-55 NV EHXL LAT LNR G5 40MM 10885862537881 148-32-51 NV EHXL 10¿ LNR G1 32MM 10885862537898 148-36-52 NV EHXL 10¿ LNR G2 36MM 10885862537904 148-36-53 NV EHXL 10¿ LNR G3 36MM 10885862537911 148-36-54 NV EHXL 10¿ LNR G4 36MM 10885862537928 148-36-55 NV EHXL 10¿ LNR G5 36MM 10885862537935 148-40-53 NV EHXL 10¿ LNR G3 40MM 10885862537942 148-40-54 NV EHXL 10¿ LNR G4 40MM 10885862537959 148-40-55 NV EHXL 10¿ LNR G5 40MM 10885862537966

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1166-2025

Related Recalls

Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a component

Exactech

Class I - Dangerous

Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.

Sep 5, 2025 Other Medical Devices View Details →

Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a component

Exactech

Class I - Dangerous

Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.

Sep 5, 2025 Other Medical Devices View Details →

Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component

Exactech

Class I - Dangerous

Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.

Sep 5, 2025 Other Medical Devices View Details →