djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurg...

FDA Device Recall #Z-1692-2020 — Class II — July 10, 2018

Recall Summary

Recall Number Z-1692-2020
Classification Class II — Moderate risk
Date Initiated July 10, 2018
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Encore Medical, LP
Location Austin, TX
Product Type Devices
Quantity 28 (14 REF S200635 and 14 S200636)

Product Description

djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the label is djosurgical, Austin, TX.

Reason for Recall

The retaining ring on the neck trials has a potential to fail interoperatively.

Distribution Pattern

Distribution was made to CA, CO, MD, MN, OH, TX, and WA. There was no foreign/military/government distribution.

Lot / Code Information

All Revision C trials. REF S-2000635: 313R1000, 313R1900, 313R1901; REF S-200636: 314R1000, 314R1900, 314R1901.

Other Recalls from Encore Medical, LP

Recall # Classification Product Date
Z-1459-2026 Class II Brand Name: EMPOWR 3D KNEE Product Name: EMPOW... Jan 15, 2026
Z-1458-2026 Class II Brand Name: Reverse Shoulder Prosthesis (RSP) ... Jan 15, 2026
Z-1460-2026 Class II Brand Name: Reverse Shoulder Prosthesis (RSP) ... Jan 15, 2026
Z-1234-2026 Class II EMPOWR Acetabular System: Liner, 10 degree Hood... Jan 5, 2026
Z-1233-2026 Class II EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: ... Jan 5, 2026

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.