Z-2430-2018Class II

Apollo XT Suture Anchor, 5.5 x 15

Name: Z-2430-2018 Apollo XT Suture Anchor, 5.5 x 15
Creator: Valeris Medical, LLC
Published: 2018-01-22
License: https://open.fda.gov/license/

Valeris Medical / initiated 2018-01-22 / Terminated / root cause: manufacturing process

FDA source

Valeris Medical, LLC began a recall of 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... on 2018-01-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2430-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-22
Posted: 2018-07-13
Terminated: 2021-04-09
Recalling firm: Valeris Medical
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
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 113 units
Distribution: US Nationwide Distribution in the states of California and Oklahoma.
Product codes and lots: Model No. XT-5515, Lot No. 2358, 2362, 2363

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2430-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2430-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-13

Product code MBI

K142230Class IIApollo Suture Anchor System and Titan ScrewsValeris Medical / cleared 2014-09-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)