Acumed LLC recalls Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose AM-0025-S 25.0mm Acutrak¿ 4/5 Bone Screw A…

Recall date

November 29, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0767-2023

FDA classification

Class II

Brand / firm

Acumed LLC

Sold / distributed

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…

Why it was recalled

Distribution without Pre-Market Clearance

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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