Z-0959-2022 Class II
FDA device recall Z-0959-2022 was initiated by Acumed LLC on March 9, 2022 and is designated Class II. 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, iatro… Affected quantity: 506 unit.
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
- 506 unit
Product Description
4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012
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 numbers distributed between 22 AUG 2018 to 07 FEB 2022. UDI:10806378022876