Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone ...
FDA Device Recall #Z-0737-2023 — Class III — November 7, 2022
Recall Summary
| Recall Number | Z-0737-2023 |
| Classification | Class III — Low risk |
| Date Initiated | November 7, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Howmedica Osteonics Corp. |
| Location | Mahwah, NJ |
| Product Type | Devices |
| Quantity | 20 units |
Product Description
Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001
Reason for Recall
Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.
Distribution Pattern
International distribution in the country of Turkey.
Lot / Code Information
UDI# P/N 6197-1-001 (01)07613327128741 (17)230331(10)lot# GTIN: 07613327128741-Instructions for Use (IFU) received with product: 0700-7-012 (IFU Radiopaque Bone Cement) All lots manufactured under Rev AB, which with expiration date on/after October 28, 2021
Other Recalls from Howmedica Osteonics Corp.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1572-2026 | Class II | MICS3 Angled Sagittal Saw Attachment; Part Num... | Feb 2, 2026 |
| Z-0963-2026 | Class II | The Stryker CranialMask Tracker is a single-use... | Nov 12, 2025 |
| Z-2640-2025 | Class II | 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Num... | Aug 28, 2025 |
| Z-0023-2025 | Class II | Triathlon Universal TS Baseplate Size 2 - A sin... | Sep 4, 2024 |
| Z-0044-2025 | Class II | MAKO Integrated Cutting System (MICS) HANDPIECE... | Aug 7, 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.