Device product
4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012
Z-0959-2022
Product summary
- Firm
- Acumed LLC
- Event
- Event 89771
- Status
- Completed
- Classification
- Class II
- Quantity
- 506 unit
- Official record key
device-enforcement:Z-0959-2022
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 numbers distributed between 22 AUG 2018 to 07 FEB 2022. UDI:10806378022876
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
bone fragments