Class II — Acumed LLC
| Recalling firm | ACUMED LLC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Distribution without Pre-Market Clearance |
| Product | AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist® Acutrak Compression Screw AI-0012-S 12mm AcuTwist® Acutrak Compression Screw AI-0014-S 14mm AcuTwist® Acutrak Compression Screw AI-0016-S 16mm AcuTwist® Acutrak Compression Screw AI-0018-S 18mm AcuTwist® Acutrak Compression Screw AI-0020 20mm AcuTwist® Acutrak Compression Screw AI-0020-S 20mm AcuTwist® Acutrak Compression Screw AI-0022-S 22mm AcuTwist® Acutrak Compression Screw AI-0024-S 24mm AcuTwist® Acutrak Compression Screw AI-0026 26mm AcuTwist® Acutrak Compression Screw AI-0026-S 26mm A… |
| Quantity | 80,805 units |
| Distribution | Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, and WY. The countries of AE, AR, AU, BE, BR, CA, CH, CL, CN, CO, CR, DE, DK, EC, ES, FI, FR, GB, GT, HK, IE, IL, IT, JP, KR, KW,… |
| Initiated | 2022-11-29 |
| Classified | 2022-12-23 |
| Recall number | Z-0769-2023 |
| 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 — Acumed LLC (Z-0769-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90996/
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