Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part ...
FDA Recall #Z-1127-2020 — Class II — December 16, 2019
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.
Recalling Firm
Nextremity Solutions — Warsaw, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
40
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated