Loading...
Loading...
All product recalls associated with Acumed LLC.
Total Recalls
33
Past Year
0
Class I (Serious)
0
Most Recent
Dec 2023
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Distribution without Pre-Market Clearance
Due to potential breakage during use.
Distribution without Pre-Market Clearance
Distribution without Pre-Market Clearance
Distribution without Pre-Market Clearance
Distribution without Pre-Market Clearance
Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage.
Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage.
Labeling may contain 2 lot numbers and 2 model numbers. It was observed that the box top label (30170060-S, W67391) does not match the two side labels (3010320-S, W67385). The part and patient labeling inside the box match the side labels (30170320-S, W67385).
Mix-up of parts - Product labeled cortical bone screw actually contains Acutract fixation screw
Products improperly handled after cleaning, prior to sanitation and may be contaminated with inorganic material.
Parts are non-functional. The user is unable to fully pass the fixator pins through the body of the Stableloc assembly as required. The kit may also be missing the set screw.
The packages for Modular Shoulder Body Assembly Left (SH-1540L-S) and Modular Shoulder Body Assembly Right (SH-1540R-S) may contain assemblies for the opposite side as indicated.
Cables of incorrect diameter were used in product assembly, resulting in the sleeve not being able to bind to the cable after crimping.
Product sterility may be compromised.
Product sterility may be compromised.
Product sterility may be compromised.
Product sterility may be compromised.
Product sterility may be compromised.
Product sterility may be compromised.