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U.S. Department of Health and Human Services

Class 2 Device Recall Novation XLE

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 Class 2 Device Recall Novation XLEsee related information
Date Initiated by FirmDecember 31, 2024
Date PostedFebruary 12, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1166-2025
Recall Event ID 96102
510(K)NumberK173583 
Product Classification Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented - Product Code OQI
ProductNovation 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.
Code Information 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
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 Nw 66th Ct
Gainesville FL 32653-1630
For Additional Information ContactMatthew Collins
352-377-1140
Manufacturer Reason
for Recall		Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 12/31/2024, the firm sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" letter via FedEx to customers initially informing them that the firm was recalling specific hip polyethylene liner lots that were inadvertently packaged without the ethylene vinyl alcohol (EVOH) layer in the innermost bag. An updated customer notification letter was communicated to affected customer via email on 01/17/2025. Customers are instructed to: -Immediate Discontinuation: Immediately discontinue use of all affected products -Quarantine and Return: Segregate and quarantine affected products and arrange for their return to Exactech. The Recall Confirmation Form section of this communication provides product return instructions. Clinical Guidance: 1. Patient Monitoring: Surgeons should regularly monitor patients with affected devices for potential risks such as device wear, failure, component cracking or fracture, new or worsening pain, bone loss and/or swelling, as per the instructions for use. 2. Diagnostic Considerations: Diagnostic imaging, such as X-rays, may be considered if device failure is suspected. 3. Revision Considerations: Revision of well-functioning devices is not recommended for patients. 4. Resources: Healthcare providers and patients with questions can access educational resources on our website exac.com/recall-information and use the device serial look-up tool. Public Contact - 352-377-1140 or email matt.collins@exac.com
Quantity in Commerce87
DistributionU.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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OQI
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