Recall Z-1166-2025 · OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
Exactech, Inc.
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 N
| Date | Feb 12, 2025 (initiated Dec 31, 2024) |
| Status | Open, Classified |
| Reason | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| Quantity | 87 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173583 | Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners Exactech, Inc., Mar 12, 2018 |