Recall Z-0768-2023

Acumed LLC · initiated November 29, 2022

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

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

Codes / lots: Acutrak 2 Fusion Device Batch Number/Part Number/Part Description/UDI Code: W74030 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-W74030000000 204349 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-204349000000 207092 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-207092000000 208497 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-208497000000 207877 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-207877000000 208095 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-208095000000 209948 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-209948000000 210146 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-210146000000 212410 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-212410000000 210147 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-210147000000 214004 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-214004000000 212916 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-212916000000 215249 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-215249000000 216130 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-216130000000 269589 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-269589000000 273212 30-0021 25.0mm…

Reason for recall

Distribution without Pre-Market Clearance

FDA-determined cause: No Marketing Application

Action taken

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 Acumed of any adverse events or product safety issues. Additionally, adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. " Complete and submit the report Online " Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178. Please complete the survey on Page 8 of this letter to indicate your receipt of this notice and to acknowledge you have read the content of this notice. Return the survey via email to RecallNotification@acumed.net. For questions - contact Acumed Business Services via email at BusinessServices@acumed.net or via phone at (888) 627-9957 Option 4 (US and Canada) or +001 (503) 627-9957 and choose Option 4 (outside of US and Canada)

Details

Recall number
Z-0768-2023
Initiated
November 29, 2022
Posted by FDA
December 23, 2022
Product code
HWC – Screw, Fixation, Bone
Quantity
1,681,860 units (Acutrak 2 286,026; Micro Acutrak 2 524,566; Mini Acutrak 2 609,220; Standard Acutrak 262,048)
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…
Recalling firm
Acumed LLC, Hillsboro, OR

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0767-2023 Class IIPart Number/Part Description: 30-0033-S 30mm Acutrak Fusion Device 6mm Nose AM-0025-S…Distribution without Pre-Market Clearance 11/29/2022Open, Classified
Z-0769-2023 Class IIAcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm…Distribution without Pre-Market Clearance 11/29/2022Open, Classified
Z-0770-2023 Class IIDual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak…Distribution without Pre-Market Clearance 11/29/2022Open, Classified