Reported Jul 25, 2018 · Terminated
Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors are intended for: Shoulder - Rotator Cuff…
Valeris Medical, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Valeris Medical, LLC · 200 Cobb Pkwy N Bldg 200 Ste 210 · Marietta, GA · 30062-3500
Is this the product you have?
- Apollo XT Suture Anchor, 5.5
- x 15 Product UsageApollo
- XT Suture Anchors are intended forShoulder - 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
- Lot codes and dates
Model No. XT-5515Lot No. 235823622363
- Amount recalled
- 113 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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