Z-1127-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2020
- Initiation Date
- December 16, 2019
- Termination Date
- September 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40
Product Description
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.
Reason for Recall
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.
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.
Code Information
Lot M1502