Z-1127-2020 Class II Terminated

Recalled by Nextremity Solutions — Warsaw, IN

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