Device product
Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation.
Z-1127-2020
Product summary
- Event
- Event 84694
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40
- Official record key
device-enforcement:Z-1127-2020
Official wording
Reason: The product contains a different plate than indicated by the package labeling. The product is labeled as a right plate but contains a left plate.
Code information: Lot M1502
Distribution pattern: Domestic distribution to AL, CA, FL, GA, ID, IL, IA, KY, LA, ME, MA, MI, MN, MS, NE, NJ, NY, OH ,OK, OR, TX, and WA.
Derived failure modes
-
Unknown
The product contains a different plate than indicated by the package labeling. The product is labeled as a right plate but contains a left plate.