FDA Medical devices recall · February 19, 2025

Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR… recall

Read the official FDA notice ↗

Product

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.

Why was it recalled?

Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

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 28

Distribution

U.S.: AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MN, NV, NY, OH, OK, PR,SC, TN, TX and VA O.U.S.: Argentina, Colombia, Germany, Guatemala, Japan and Spain

States: Arkansas California Colorado Florida Georgia Hawaii Illinois Indiana Kansas Kentucky Louisiana Maryland Minnesota Nevada New York Ohio Oklahoma Puerto Rico South Carolina Tennessee Texas Virginia

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-1166-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.