Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose Recalled by Acumed LLC Due to Distribution without Pre-Market Clearance
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Acumed LLC directly.
Affected Products
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
Quantity: Total 306,934 units (Acutrak 239,611 units and Mini Acutrak 67,323)
Why Was This Recalled?
Distribution without Pre-Market Clearance
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Acumed LLC
Acumed LLC has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report