FDA Medical devices recall · February 19, 2025

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

Read the official FDA notice ↗

Product

Alteon 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: 01-030-40-0022 ALT XLE LNRNTRL G0 22 10885862549433 Serial Numbers: 6771453 6771460 6771467 6771484 6771458 6771456 6771468 6771479 6771444 6771461 6771470 6771474 6771481 01-030-40-0122 ALT XLE LNRNTRL G1 22 10885862549440 01-030-40-0128 ALT XLE LNR NTRL G1 28 10885862549457 Serial Numbers: 6515426 6515434 6750140 6750151 6597399 6597410 6750127 6750132 6750145 6906249 6515440 6597407 6597409 6515443 6597398 6597408 6515428 6750152 6597400 6515441 6515442 6597403 6750164 6906241 6906245 6906258 01-030-40-0222 ALT XLE LNRNTRL G2 22 10885862549464 01-030-40-0228 ALT XLE LNR NTRL G2 28 10885862549471 Serial Numbers: 6532932 6532935 01-030-40-0232 ALT XLE LNR NTRL G2 32 10885862549488 Serial Numbers: 6904616 6436003 6486043 6512970 6512972 6592041 6592052 6838572 6838573 6838629 6904466 6904461 6602279 6602314 6602327 6712220 6826324 6477677 6477682 6602303 6712155 6712221 6838656 6904499 6904606 6486040 6486053 7010390 6838577 6838636 6838651 6904486 6477683 6477717 6904493 6712152 6826293 6838618 7010361 6904495 6592040 6602310 6712167 6592060 6602294 6838648 6712153 6712209 6602316 6712171 6838622 6436004 6477694 6512971 6602304 6826290 6826296 6826303 6838640 6486034 6486044 6592044 6592045 6592064 6592073 6602289 6712193 6826338 6838630 6904473 6904617 6904641 01-030-40-0322 ALT XLE LNR NTRL G3 22 10885862549495 01-030-40-0328 ALT XLE LNR NTRL G3 28 10885862549501 Serial Numbers: 6532515 6532527 01-030-40-0332 ALT XLE LNR NTRL

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-1167-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.