# FDA recall Z-2430-2018

> **Valeris Medical, LLC** · Class II · device recall initiated 2018-01-22.

## 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

## 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.

## Distribution

US Nationwide Distribution in the states of California and Oklahoma.

## Key facts

- **Recall number:** Z-2430-2018
- **Recalling firm:** Valeris Medical, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-22
- **Report date:** 2018-07-25
- **Termination date:** 2021-04-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marietta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2430-2018

## Citation

> AI Analytics. FDA recall Z-2430-2018. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-2430-2018. Source: US FDA. Licensed CC0.

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