FDA-Device2020-02-19Class II

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.

Nextremity Solutions
Hazard

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.

Sold states
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.
Affected count
40
Manufactured in
6210 N Buffalo St, Warsaw, IN, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1127-2020

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