Recall Z-1165-2025 · OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
Exactech, Inc.
AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0 LNR G 28MM 140-32-27 AM EHXL 0 LNR G 32MM 140-32-28 AM EHXL 0 LNR H 32MM 140-28-29 AM EHXL 0 LNR J 28MM 140-32-29 AM EHXL 0 LNR J 32MM 140-36-29 AM EHXL 0 LNR J 36MM 140-32-30 AM EHXL 0 LNR K 32MM 140-36-30 AM EHXL 0 LNR K 36MM 140-28-25 AM EHXL 0LNR E 28MM 140-28-26 AM EHXL 0LNR F 28MM 140-28-28 AM EHXL 0LNR H 28MM 140-36-28 AM E
| 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 | 42 |
| 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 |