Device product
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.
Z-0265-2022
Product summary
- Event
- Event 88975
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 224 units
- Official record key
device-enforcement:Z-0265-2022
Official wording
Reason: The labels on the packages of screws were switched.
Code information: REF 72413575 - batch #21FM24289; REF 72413570 - batch #21GM04743.
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.
Derived failure modes
-
Labeling or packaging
labels on the packages of screws were switched