Nextremity Solutions recalls Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Pl…

Recall date

December 16, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1127-2020

FDA classification

Class II

Brand / firm

Nextremity Solutions

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.