Valeris Medical, LLC recalls Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors are intended for: Shoulder - Rotator Cuff Rep…

Recall date

January 22, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2430-2018

FDA classification

Class II

Brand / firm

Valeris Medical, LLC

Sold / distributed

US Nationwide Distribution in the states of California and Oklahoma.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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