CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONLY, NON STERILE Or...

FDA Device Recall #Z-2604-2014 — Class II — July 30, 2014

Recall Summary

Recall Number Z-2604-2014
Classification Class II — Moderate risk
Date Initiated July 30, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Wright Medical Technology, Inc.
Location Memphis, TN
Product Type Devices
Quantity 178 units

Product Description

CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONLY, NON STERILE Orthopedic

Reason for Recall

Plates manufactured from an incorrect raw material.

Distribution Pattern

Worldwide Distribution - USA (Nationwide) and Internationally to Canada Australia, Great Britain, Germany, Spain, Netherlands, France.

Lot / Code Information

Lot Numbers: 1487670, 1487671, 1487672, 1512149, 1519496, 1523745, 1534796, 1537159, 1539400, 1540714

Other Recalls from Wright Medical Technology, Inc.

Recall # Classification Product Date
Z-1477-2024 Class II stryker Infinity Resection Adjustment Block, RE... Mar 6, 2024
Z-2105-2023 Class II Stryker Infinity Alignment Frame Distal Sub-Ass... Jun 13, 2023
Z-1467-2023 Class II stryker ORTHOLOC 3Di Fusion Plate MTP Right, RE... Apr 10, 2023
Z-1466-2023 Class II stryker ORTHOLOC 3Di Fusion Plate MTP Right, RE... Apr 10, 2023
Z-1170-2023 Class II ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, ... Feb 2, 2023

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.