Recall Z-0769-2023 ยท HWC Screw, Fixation, Bone
Acumed LLC
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 Comp
| Date | Dec 23, 2022 (initiated Nov 29, 2022) |
| Status | Open, Classified |
| Reason | Distribution without Pre-Market Clearance |
| Root cause | No Marketing Application |
| Action | On 11/29-30/2022, Acumed LLC sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter via USPS First Class with signature required to customers informing them that the Acutrak Headless Compression Screws and the Acutrak 2 Headless Compression Screw Systems were commercialized with a Pre-Market Clearance (510(k)). Customer are instructed to: Product within the scope of this correction does not need to be returned to Acumed. No actions are required as this is a compliance issue and not a patient safety issue. This notification is solely for your awareness. However, physicians are urged to notify Ac |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221333 | Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional Acumed, LLC, Dec 29, 2022 |