Recall Z-2430-2018 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Valeris Medical, LLC
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 Ligam
| Date | Jan 22, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| 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 |
| Quantity | 113 units |
| Distribution | US Nationwide Distribution in the states of California and Oklahoma. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142230 | Apollo Suture Anchor System and Titan Screws Valeris Medical, Sep 10, 2014 |