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Recall Observatory FDA recall evidence

Device product

4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010

Z-0958-2022

March 09, 2022

Class II

Product summary

Firm
Acumed LLC
Event
Event 89771
Status
Completed
Classification
Class II
Quantity
537 units
Official record key
device-enforcement:Z-0958-2022

Official wording

Reason: 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.

Code information: All Batch number distributed between 22 AUG 2018 to 07 FEB 2022 . UDI : 10806378022869

Distribution pattern: 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.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    bone fragments