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Acumed LLC recalls 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
Recalled April 27, 2022 · FDA recall Z-0958-2022 · Acumed
Hazard
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. · FDA Class II
Units
537 units
Sold at
Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, Puerto Rico and the country of South Africa.
Description
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.
Product
4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
Manufacturer(s)
Acumed LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →