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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

FDA Recall Z-2430-2018 · Posted None

Recalling FirmValeris Medical, LLC
Recall StatusTerminated
Product CodeMBI
Date Initiated2018-01-22
Date Terminated2021-04-09
Product Quantity113 units

Reason for Recall

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

US Nationwide Distribution in the states of California and Oklahoma.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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