FDA recall Z-1127-2020

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.

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

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.

Key facts

Status

Terminated

Initiation date

2019-12-16

Report date

2020-02-19

Termination date

2020-09-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

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