4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012
Check against the official notice below — it lists the full affected range.
Acumed LLC is recalling 506 units of 4.0mm x 10mm and 4.0mm x 12mm Cannulated Screws (Part number 3005-40012) due to insufficient axial pullout strength for their intended use. The affected screws were distributed worldwide and throughout the United States, including Puerto Rico and South Africa, with batch numbers produced between August 22, 2018 and February 7, 2022.
These screws may fail to hold bone fragments together properly, potentially resulting in improper bone healing, new fractures, joint damage, or soft tissue injury. The source document does not specify what remedy is available to 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: 506 unit Lot/code info: All Batch numbers distributed between 22 AUG 2018 to 07 FEB 2022. UDI:10806378022876
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.