2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, os...

FDA Device Recall #Z-0323-2016 — Class II — November 2, 2015

Recall Summary

Recall Number Z-0323-2016
Classification Class II — Moderate risk
Date Initiated November 2, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Synthes (USA) Products LLC
Location West Chester, PA
Product Type Devices
Quantity 229

Product Description

2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.

Reason for Recall

It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment LCP System).

Distribution Pattern

Distributed in the states of IA, OH, CO, FL, TX, MA, NY, OR, SC, VA, WV, TN, MO, PA, CT, GA, WA, CA, AL, , IN, MI, NJ, VT, ID, KS, MN, and MD, and the country of Canada.

Lot / Code Information

Part Number Lot Number Product Description 212.818 7856527 Synthes 2.4mm Locking Screw SLF-TPNG with Stardrive Recess 18mm

Other Recalls from Synthes (USA) Products LLC

Recall # Classification Product Date
Z-0228-2026 Class II LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM... Sep 26, 2025
Z-0229-2026 Class II LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM... Sep 26, 2025
Z-1916-2024 Class II STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/... Apr 25, 2024
Z-1239-2024 Class II TFNA Femoral Nail 9mm, right, 130¿, L 235mm-In... Jan 24, 2024
Z-1238-2024 Class II RAPIDSORB IPS Battery Pack, Sterile-Intended fo... Jan 24, 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.