FDA Recall Open, Classified

Part Number/Part Description: 30-0033-S 30mm Acutrak Fusion Device 6mm Nose AM-0025-S 25.0mm Acutrak 4/5 Bone Screw AM-0030-S 30.0mm Acutrak 4/5 Bone Screw AM-0035-S 35.0mm Acutrak 4/5 Bone Screw AM-0040-S 40.0mm Acutrak 4/5 Bone Screw AM-0045-S 45.0mm Acutrak 4/5 Bone Screw AM-0050-S 50.0mm Acutrak 4/5 Bone Screw AP-67100-S 100mm Acutrak 6/7 Fixation Screw AP-67105-S 105mm Acutrak 6/7 Fixation Screw AP-67110-S 110mm Acutrak 6/7 Fixation Screw AP-67115-S 115mm Acutrak 6/7 Fixation Screw AP-67120-S 120mm Acutrak 6/7 Fixation Screw AP-6740-S 40mm Acutrak 6/7 Fixation Screw AP-6745-S 45mm Acutrak 6/7 Fixation Screw AP-6750-S 50mm Acutrak 6/7 Fixation Screw AP-6755-S 55mm Acutrak 6/7 Fixation Screw AP-6760-S 60mm Acutrak 6/7 Fixation Screw AP-6765-S 65mm Acutrak 6/7 Fixation Screw AP-6770-S 70mm Acutrak 6/7 Fixation Screw AP-6775-S 75mm Acutrak 6/7 Fixation Screw AP-6780-S 80mm Acutrak 6/7 Fixation Screw AP-6785-S 85mm Acutrak 6/7 Fixation Screw AP-6790-S 90mm Acutrak 6/7 Fixation Screw AP-6795-S 95mm Acutrak 6/7 Fixation Screw ATF-140-S 14.0mm Acutrak Fusion Device ATF-160-S 16.0mm Acutrak Fusion Device ATF-180-S 18.0mm Acutrak Fusion Device ATF-200-S 20.0mm Acutrak Fusion Device ATF-220-S 22.0mm Acutrak Fusion Device ATF-240-S 24.0mm Acutrak Fusion Device ATF-270-S 27.0mm Acutrak Fusion Device ATF-320-S 32.0mm Acutrak Fusion Device ATF-370-S 37.0mm Acutrak Fusion Device ATM-100-S 10.0mm Mini Acutrak Fixation Screw ATM-120-S 12.0mm Mini Acutrak Fixation Screw ATM-140-S 14.0mm Mini Acutrak Fixation Screw ATM-160-S 16.0mm Mini Acutrak Fixation Screw ATM-180-S 18.0mm Mini Acutrak Fixation Screw ATM-200-S 20.0mm Mini Acutrak Fixation Screw ATM-220-S 22.0mm Mini Acutrak Fixation Screw ATM-240-S 24.0mm Mini Acutrak Fixation Screw ATM-260-S 26.0mm Mini Acutrak Fixation Screw

Recall: Z-0767-2023 · Initiated November 29, 2022

Recall

Recall Number: Z-0767-2023
Event Number: 90996
Firm: Acumed LLC
FEI Number: 1000125930
Product Code: HWC
Status: Open, Classified
Root Cause: No Marketing Application
Initiated: November 29, 2022
Posted: December 23, 2022
Address: 5885 NW Cornelius Pass Rd, Hillsboro, OR, 97124-9370

Description

Reason

Distribution without Pre-Market Clearance

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 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 [email protected]. For questions - contact Acumed Business Services via email at [email protected] 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)

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, KW, MX, MY, PA, PE, PR, PT, QA, SA, SE, SG, TH, TR, TW, and ZA.

Quantity

Total 306,934 units (Acutrak 239,611 units and Mini Acutrak 67,323)