Acumed LLC: Medical Device Recall in 2022 - (Recall #: Z-0958-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 9, 2022

Date Posted: April 27, 2022

Recall Number: Z-0958-2022

Event ID: 89771

Reason for Recall:

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.

Status: Completed

Product Quantity: 537 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated