Z-0265-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 24, 2021
- Initiation Date
- October 25, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 224 units
Product Description
Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.
Reason for Recall
The labels on the packages of screws were switched.
Distribution Pattern
Distribution was made to AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, and WA. There was no direct government distribution. There was no military distribution. Foreign distribution was made to Australia, Canada, China, Dubai/MENA, Germany, Italy, Japan, Netherlands, Singapore, and Thailand.
Code Information
REF 72413575 - batch #21FM24289; REF 72413570 - batch #21GM04743.