Z-0958-2022 Class II
Recall Details
- Product Type
- Devices
- Report Date
- April 27, 2022
- Initiation Date
- March 9, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 537 units
Product Description
4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
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 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.
Code Information
All Batch number distributed between 22 AUG 2018 to 07 FEB 2022 . UDI : 10806378022869