Acumed LLC recalls 4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012

Recall date

March 9, 2022

Source

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

Recall number

Z-0959-2022

FDA classification

Class II

Brand / firm

Acumed LLC

Sold / distributed

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.

Why it was recalled

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.

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

What was recalled

4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012