BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0534-2020 · Initiated October 9, 2019

    Recall

    Recall Number
    Z-0534-2020
    Event Number
    84160
    Firm
    Nextremity Solutions
    FEI Number
    3009540749
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    October 9, 2019
    Terminated
    June 24, 2020
    Address
    6210 N Buffalo St, Warsaw, IN, 46580

    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.

    Reason

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

    Action

    Nextremity Solutions issued Urgent Medical Device notification dated 10/09/19, identifying product, reason for recall, health risk and action to take: review inventory , quarantine for product for return and contact your Zimmer Biomet Rep. will remove product from your facility. Complete and return the Medical Device Response Form. Questions contact customer service 574-371-3071, 8 am-5pm, M-F (EST).

    Distribution

    US Nationwide distribution.

    Quantity

    49 units