FDA Device recall Z-0769-2023
AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw AI-0012-S 12mm AcuTwis…
- FDA Device
- Class II
- ongoing
- Published 2023-01-04
On 2023-01-04 the FDA classified a Class II recall of AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw AI-0012-S 12mm AcuTwis… by Acumed, citing distribution without Pre-Market Clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0769-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-29 |
| Published | 2023-01-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Acumed |
| Distribution | US |
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 AcuTwist¿ Acutrak Compression Screw AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw AI-0030 30mm AcuTwist¿ Acutrak Compression Screw AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw
Reason
Distribution without Pre-Market Clearance
Identifiers
| code_info | AcuTwist Acutrak Compression Device Batch Number/Part Number/Part Description/UDI Code: 204010 AI-0010-S 10mm AcuTwist¿…AcuTwist Acutrak Compression Device Batch Number/Part Number/Part Description/UDI Code: 204010 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-204010000000160531 219050 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-219050000000170130 226652 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-226652000000170531 236972 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-236972000000171231 239079 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-239079000000180131 260403 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-260403000000181231 265390 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-265390000000190228 270950 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-270950000000190331 273603 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-273603000000190731 278305 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-27830500000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0769-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.