ModerateClass IITerminated

FDA Devices recall · Reported July 25, 2018

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

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on July 25, 2018. Severity: Moderate. Recall number: Z-2430-2018.

Q: Where was the recalled product distributed?

Distribution: US Nationwide Distribution in the states of California and Oklahoma..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-2430-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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 …

Recall #: Z-2430-2018
Affected scope: 113 units
Initiated: January 22, 2018

Compiled from official public sources by the editorial team.

Verify with FDA Devices →

View my saved recalls

Valeris Medical, LLC recalled Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors are intende… - a moderate-severity action.

Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors are intende… was recalled by Valeris Medical, LLC in July 25, 2018. Reason: The label on Apollo XT 5.5mm Suture Anchor (part # XTS-5515; lots 2358, 2362, and 2363) indicated that the an…. Check the official notice for the remedy. Verify recall #Z-2430-2018 with the FDA Devices before acting.

Share: Post Facebook LinkedIn WhatsApp Email

The recall

Valeris Medical, LLC issued this moderate-severity FDA Devices recall-The label on Apollo XT 5.5mm Suture Anchor (part # XTS-5515; lots 2358, 2362, and 2363) indicated that the an….

Moderate
severity level: 113 units
affected scope: Class II
classification: July 25, 2018
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2430-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-2430-2018) was formally reported on July 25, 2018, with the manufacturer initiating the action on January 22, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Valeris Medical, LLC is listed as the recalling firm, operating out of Marietta, GA. Federal records list the affected scope as 113 units.

The documented reason for this recall is: 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 data in the federal record shows the product reached: US Nationwide Distribution in the states of California and Oklahoma.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

113 units

Related Recalls

0 from same agency

Product description

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-2430-2018
Date reported	July 25, 2018
Date initiated	January 22, 2018
Recalling firm	Valeris Medical, LLC
Firm location	Marietta, GA
Affected scope	113 units
Distribution	US Nationwide Distribution in the states of California and Oklahoma.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

113 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-2430-2018) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

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.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on July 25, 2018. Severity: Moderate. Recall number: Z-2430-2018.

Where was the recalled product distributed? ▼

Distribution: US Nationwide Distribution in the states of California and Oklahoma..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-2430-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nearby Recalls in This Category

Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.

CPSC Moderate

Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards

· 2026-07-02

CPSC Moderate

Winco Fireworks International Recalls Roman Candles 8 Shot Fireworks Due to Risk of Serious Injury from Explosion and B…

· 2026-07-02

CPSC Moderate

Winco Fireworks International Recalls Unity 7 Shot 200 Gram Aerial Cake Fireworks Due to Risk of Serious Injury from Ex…

· 2026-07-02

CPSC Moderate

Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury f…

· 2026-06-25

CPSC Moderate

Super Off-Road Solar Power Banks Recalled Due to Overheating; Imported by Spector & Co.

· 2026-06-25

Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →

Browse all Medical Devices recalls →

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 25, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.