Recall Z-0767-2023

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

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

Codes / lots: Acutrak Fusion Device Batch Number/Part Number/Part Description/UDI Code: W73862 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-W73862000000151231 W73867 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-W73867000000160130 W73860 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-W73860000000160131 W73865 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-W73865000000160131 W73866 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-W73866000000160131 W73868 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-W73868000000160131 W73863 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-W73863000000160131 230712 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-230712000000170630 233448 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-233448000000170831 237340 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-237340000000171130 241394 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-241394000000180130 244824 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-244824000000180228 249049 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose…

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-0767-2023
Initiated
November 29, 2022
Posted by FDA
December 23, 2022
Product code
HWC – Screw, Fixation, Bone
Quantity
Total 306,934 units (Acutrak 239,611 units and Mini Acutrak 67,323)
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-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-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