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Sources: EU EUDAMED, US FDA
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FDA Recall
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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
FDA Recall
Terminated
·Valeris Medical, LLC·Product code MBI·January 22, 2018
Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 15mm, each package contains (1) PEEK Screw, (1) #2 ForceBraid Blue, and (1) #2 ForceBraid White, 5 packages per container, Sterile, Rx. The firm name on the label is Valeris Medical, Marietta, GA.
FDA Recall
Terminated
·Valeris Medical, LLC·Product code MBI·July 16, 2018