Nextremity Solutions: Medical Device Recall in 2019 - (Recall #: Z-0534-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.
Product Description:

Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and small bone segments, particularly in osteopenic bone.

Product Classification:

Class II

Date Initiated: October 9, 2019
Date Posted: December 4, 2019
Recall Number: Z-0534-2020
Event ID: 84160
Reason for Recall:

Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length

Status: Terminated
Product Quantity: 49 units
Code Information:

Lot Number: M1151 UDI: 00817701022558

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated