Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of th...

FDA Device Recall #Z-1086-2014 — Class II — December 18, 2013

Recall Summary

Recall Number Z-1086-2014
Classification Class II — Moderate risk
Date Initiated December 18, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Stryker Spine
Location Allendale, NJ
Product Type Devices
Quantity 21 units

Product Description

Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand . It is used for implant insertion in to the disc space. The AVS navigator Peek Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal fixation. These hollow implants are offered in a variety of lengths, heights and lordotic angles designed to adapt to different patient anatomies. They have serrations on the superior and inferior surfaces designed for multidirectional fixation and ergonomically shaped anterior edges and flat posterior edges.

Reason for Recall

Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter.

Distribution Pattern

US Nationwide Distribution

Lot / Code Information

D109140 Catalog # IS3009AVS Lot Serial # 3664, 3759, 3843, 3913, 4079, 4195 and 4242

Other Recalls from Stryker Spine

Recall # Classification Product Date
Z-1489-2025 Class II Monterey AL Implant Inserter; 14/16mm; Catalog ... Feb 28, 2025
Z-1490-2025 Class II Monterey AL Implant Inserter; 18/20mm; Catalog ... Feb 28, 2025
Z-1491-2025 Class II Monterey AL Implant Inserter; 22mm; Catalog 480... Feb 28, 2025
Z-1488-2025 Class II Monterey AL Implant Inserter; 10/12mm; Catalog ... Feb 28, 2025
Z-3210-2024 Class II AVS Anchor-C Cervical Cage System Instructions ... Aug 23, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.