FDA Medical Device Recalls (openFDA)
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 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
- Recall number
- Z-2430-2018
- Recalling firm
- Valeris Medical, LLC
- Product
- 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
- Status
- Terminated
- Initiated
- 2018-01-22
- Posted
- not on file
- Terminated
- 2021-04-09
- 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 has been completed.
- Quantity
- 113 units
- Distribution
- US Nationwide Distribution in the states of California and Oklahoma.
- Lot, serial or model codes
- Model No. XT-5515, Lot No. 2358, 2362, 2363
- 510(k) numbers
- ["K142230"]
- PMA numbers
- not on file
- Product code
- MBI
- Firm FEI
- 3010841252
- Firm city
- Marietta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28