Recall record at a glance
| Official record | Z-0768-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Acumed LLC |
| Report date | Jan 4, 2023 |
| Recall initiation date | Nov 29, 2022 |
| Quantity | 1,681,860 units (Acutrak 2 286,026; Micro Acutrak 2 524,566; Mini Acutrak 2 609,220; Standard Acutrak 262,048) |
| Location | Hillsboro, OR, United States |
Official product description
Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2 - 5.5 Screw 30-0021-S 25.0mm Acutrak 2 - 5.5 Screw 30-0023 30.0mm Acutrak 2 - 5.5 Screw 30-0023-S 30.0mm Acutrak 2 - 5.5 Screw 30-0025 35.0mm Acutrak 2 - 5.5 Screw 30-0025-S 35.0mm Acutrak 2 - 5.5 Screw 30-0027 40.0mm Acutrak 2 - 5.5 Screw 30-0027-S 40.0mm Acutrak 2 - 5.5 Screw 30-0029 45.0mm Acutrak 2 - 5.5 Screw 30-0029-S 45.0mm Acutrak 2 - 5.5 Screw 30-0031 50.0mm Acutrak 2 - 5.5 Screw 30-0031-S 50.0mm Acutrak 2 - 5.5 Screw 30-0084 55.0mm Acutrak 2 - 5.5 Screw 30-0084-S 55.0mm Acutrak 2 - 5.5 Screw 30-0085 60.0mm Acutrak 2 - 5.5 Screw 30-0085-S 60.0mm Acutrak 2 - 5.5 Screw 30-0620 20.0mm Acutrak 2 - 4.7 Screw 30-0620-S 20.0mm Acutrak 2 - 4.7 Screw 30-0622 22.0mm Acutrak 2 - 4.7 Screw 30-0622-S 22.0mm Acutrak 2 - 4.7 Screw 30-0624 24.0mm Acutrak 2 - 4.7 Screw 30-0624-S 24.0mm Acutrak 2 - 4.7 Screw 30-0626 26.0mm Acutrak 2 - 4.7 Screw 30-0626-S 26.0mm Acutrak 2 - 4.7 Screw 30-0628 28.0mm Acutrak 2 - 4.7 Screw 30-0628-S 28.0mm Acutrak 2 - 4.7 Screw 30-0630 30.0mm Acutrak 2 - 4.7 Screw 30-0630-S 30.0mm Acutrak 2 - 4.7 Screw 30-0635 35.0mm Acutrak 2 - 4.7 Screw 30-0635-S 35.0mm Acutrak 2 - 4.7 Screw 30-0640 40.0mm Acutrak 2 - 4.7 Screw 30-0640-S 40.0mm Acutrak 2 - 4.7 Screw 30-0645 45.0mm Acutrak 2 - 4.7 Screw 30-0645-S 45.0mm Acutrak 2 - 4.7 Screw 30-0650 50.0mm Acutrak 2 - 4.7 Screw 30-0650-S 50.0mm Acutrak 2 - 4.7 Screw 30-0740 40.0mm Acutrak 2 - 7.5 Screw 30-0740-S 40.0mm Acutrak 2 - 7.5 Screw 30-0745 45.0mm Acutrak 2 - 7.5 Screw 30-0745-S 45.0mm Acutrak 2 - 7.5 Screw 30-0750 50.0mm Acutrak 2 - 7.5 Screw 30-0750-S 50.0mm Acutrak 2 - 7.5 Screw 30-0755 55.0mm Acutrak 2 - 7.5 Screw 30-0755-S 55.0mm Acutrak 2 - 7.5 Screw 30-0760 60.0mm Acutrak 2 - 7.5 Screw 30-0760-S 60.0mm Acutrak 2 - 7.5 Screw 30-0770 70.0mm Acutrak 2 - 7.5 Screw 30-0770-S 70.0mm Acutrak 2 - 7.5 Screw 30-0775 75.0mm Acutrak 2 - 7.5 Screw 30-0775-S 75.0mm Acutrak 2 - 7.5 Screw 30-0780 80.0mm Acutrak 2 - 7.5 Screw 30-0780-S 80.0mm Acutrak 2 - 7.5 Screw 30-0785 85.0mm Acutrak 2 - 7.5 Screw 30-0785-S 85.0mm Acutrak 2 - 7.5 Screw 30-0790 90.0mm Acutrak 2 - 7.5 Screw 30-0790-S 90.0mm Acutrak 2 - 7.5 Screw 30-0795 95.0mm Acutrak 2 - 7.5 Screw 30-0795-S 95.0mm Acutrak 2 - 7.5 Screw 30-0800 100.0mm Acutrak 2 - 7.5 Screw 30-0800-S 100.0mm Acutrak 2 - 7.5 Screw 30-0805 105.0mm Acutrak 2 - 7.5 Screw 30-0805-S 105.0mm Acutrak 2 - 7.5 Screw 30-0810 110.0mm Acutrak 2 - 7.5 Screw 30-0810-S 110.0mm Acutrak 2 - 7.5 Screw 30-0815 115.0mm Acutrak 2 - 7.5 Screw 30-0815-S 115.0mm Acutrak 2 - 7.5 Screw 30-0820 120.0mm Acutrak 2 - 7.5 Screw Micro Acutrak 2 Part Number/Part Description: AT2-C08 through AT2-S34-S 8.0-34.0mm, Micro Acutrak 2 Bone Screw
Why the product was recalled
Distribution without Pre-Market Clearance
Distribution information
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, MX, MY, PA, PE, PR, PT, QA, SA, SE, SG, TH, TR, TW, and ZA.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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