4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
Check against the official notice below — it lists the full affected range.
Acumed LLC is recalling 4.0mm x 10mm and 4.0mm x 12mm Cannulated Screws (Part number 3005-40010) because they may not have sufficient axial pullout strength for their intended use. These screws were distributed worldwide and throughout most U.S. states, as well as Puerto Rico and South Africa, between August 22, 2018 and February 7, 2022. A total of 537 units were affected, identifiable by their batch numbers within that date range and UDI 10806378022869.
The insufficient pullout strength poses a remote possibility of bone fragments failing to heal properly or healing incorrectly, iatrogenic fracture, joint impingement or damage, or soft tissue damage. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: 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. Quantity: 537 units Lot/code info: All Batch number distributed between 22 AUG 2018 to 07 FEB 2022 . UDI : 10806378022869
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.