Recall Z-0769-2023

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

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

Codes / lots: 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 10806378054501-278305000000190930 358993 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-358993000000220731 358079 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-358079150903220902 404026…

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-0769-2023
Initiated
November 29, 2022
Posted by FDA
December 23, 2022
Product code
HWC – Screw, Fixation, Bone
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…
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-0768-2023 Class IIAcutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2 - 5.5 Screw 30-0021-S…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