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RecallWatchMedical Device Safety
Class IIOngoingZ-1166-2025

Exactech, Inc. recalls Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 1…

Exactech, Inc.Gainesville, FL, United StatesReported Feb 19, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI-DI code
    285 affected lots
    65949436970850659537665953806858220685823069731236594924
    +277 more6970840659538365953856595381697083569708386970842659592265102766973139140-32-52G232MM10885862537270140-32-53G332MM10885862537287140-32-5432MM10885862537294140-32-5532MM10885862537300140-36-5236MM108858625373176558356642233766316756504196663167766316956631712684430466316896631699663172565583606844285684429868442816348961650417765041956504202650420466316866844321140-36-53G336MM1088586253732466000766600101660005466000576600093140-36-5436MM10885862537331140-36-5536MM10885862537348140-40-5340MM1088586253735565103146510327140-40-5440MM10885862537362140-40-5540MM10885862537379142-22-68G0022MM10885862537546142-22-70G0022MM10885862537386142-28-5028MM10885862537393142-28-5128MM10885862537409142-28-5228MM10885862537416142-28-6028MM10885862537553142-28-6128MM10885862537560142-28-6228MM10885862537577142-32-5132MM10885862537423142-32-5232MM10885862537430142-32-5332MM10885862537447142-32-5432MM10885862537454142-32-5532MM10885862537461142-32-6132MM1088586253758470400766842549655444865960056554464655445868661776596019655445765959936503270142-32-6232MM10885862537591142-32-6332MM10885862537607142-32-6432MM10885862537614142-32-6532MM10885862537621142-36-5236MM10885862537478142-36-5336MM10885862537485142-36-5436MM10885862537492142-36-5536MM10885862537508142-36-6236MM1088586253763868319976679288683198070322266679275683198363351676832001655555470322486679286667932168319926927281142-36-6336MM10885862537645142-36-6436MM10885862537652142-36-6536MM10885862537669142-40-5340MM10885862537515142-40-5440MM10885862537522142-40-5540MM10885862537539142-40-6340MM108858625376766452595142-40-6440MM10885862537683142-40-6540MM10885862537690146-22-70G0022MM10885862537751146-28-5128MM10885862537768146-32-5132MM10885862537775146-32-5232MM10885862537782146-32-5332MM10885862537799146-32-5432MM10885862537805146-32-5532MM10885862537812146-36-5236MM10885862537829146-36-5336MM10885862537836146-36-5436MM10885862537843146-36-5536MM10885862537850146-40-5340MM1088586253786766022556602261660226566022686602269660227066022726602256660226366022676602277660225766022586602273146-40-5440MM10885862537874146-40-5540MM10885862537881148-32-5132MM10885862537898148-36-5236MM10885862537904148-36-5336MM10885862537911148-36-5436MM10885862537928148-36-5536MM10885862537935148-40-5340MM10885862537942148-40-5440MM10885862537959148-40-5540MM10885862537966

What the firm is doing

On 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

DistributionShow details

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

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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