BEUDAMED
    FDA Recall Terminated

    Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors are intended for: Shoulder - Rotator Cuff Repair - Bankart Repair - SLAP Lesion Repair - Biceps Tenodesis - Acromio-Clavicular Separation Repair - Deltoid Repair - Capisular Shift or Capsulolabral Reconstruction Foot/Ankle - Lateral Stabilization - Medial Stabilization - Achilles Tendon Repair Knee - Medial Collateral Ligament Repair - Lateral Collateral Ligament Repair - Posterior Oblique Ligament Repair - Illiotibial Band Tenodesis Elbow - Biceps Tendon Reattachment - Ulnar or Radial Collateral Ligament Reconstruction Hip - Capsular Repair - Acetabular Labral Repair

    Recall: Z-2430-2018 · Initiated January 22, 2018

    Recall

    Recall Number
    Z-2430-2018
    Event Number
    80069
    Firm
    Valeris Medical, LLC
    FEI Number
    3010841252
    Product Code
    MBI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 22, 2018
    Terminated
    April 9, 2021
    Address
    200 Cobb Pkwy N, Bldg 200 Ste 210, Marietta, GA, 30062-3500

    Description

    Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors are intended for: Shoulder - Rotator Cuff Repair - Bankart Repair - SLAP Lesion Repair - Biceps Tenodesis - Acromio-Clavicular Separation Repair - Deltoid Repair - Capisular Shift or Capsulolabral Reconstruction Foot/Ankle - Lateral Stabilization - Medial Stabilization - Achilles Tendon Repair Knee - Medial Collateral Ligament Repair - Lateral Collateral Ligament Repair - Posterior Oblique Ligament Repair - Illiotibial Band Tenodesis Elbow - Biceps Tendon Reattachment - Ulnar or Radial Collateral Ligament Reconstruction Hip - Capsular Repair - Acetabular Labral Repair

    Reason

    The label on Apollo XT 5.5mm Suture Anchor (part # XTS-5515; lots 2358, 2362, and 2363) indicated that the anchor screw material was titanium, however that part number is made of PEEK.

    Action

    Valeris Medical notified customers on approximately 01/20/2018 via phone call, text, or email. A formal letter was mailed to customers on 02/09/2018. The letter identified the affected product, problem and actions to be taken. Customers were instructed to remove affected products from inventory to quarantine, affix replacement labels provided by Valeris over the current labeling, and notify any customers if product was further distributed to so the product can be quarantined and returned for labeling. Additionally, Valeris requested confirmation in writing that the field correction action has been completed.

    Distribution

    US Nationwide Distribution in the states of California and Oklahoma.

    Quantity

    113 units