FDA-Device2022-04-27Class II
4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
Acumed LLC
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.
Sold states
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.
Affected count
537 units
Manufactured in
5885 NW Cornelius Pass Rd, Hillsboro, OR, United States
Products
4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0958-2022Don't want to check this manually?
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