Class II — Exactech, Inc.
| Recalling firm | EXACTECH, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. |
| Product | 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 EHXL 0LNR H 36MM 140-28-30 AM EHXL 0LNR K 28MM 142-28-24 AM EHXL 15® LNR D 28MM 142-28-26 AM EHXL 15® LNR F 28MM 142-32-27 AM EHXL 15® LNR G 32MM 142-32-28 AM EHXL 15® LN… |
| 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 |
| Initiated | 2024-12-31 |
| Classified | 2025-02-12 |
| Recall number | Z-1165-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Exactech, Inc. (Z-1165-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96102/
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