LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-...
FDA Device Recall #Z-2350-2023 — Class II — July 3, 2023
Recall Summary
| Recall Number | Z-2350-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 3, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Location | Norderstedt, N/A |
| Product Type | Devices |
| Quantity | 24 units |
Product Description
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-119/00
Reason for Recall
Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue
Distribution Pattern
US Nationwide distribution.
Lot / Code Information
UDI-DI: 04026575182138 Lot Numbers: B922122 B932054 C005071 C211013
Other Recalls from Waldemar Link GmbH & Co. KG (Mfg Site)
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1652-2026 | Class II | Embrace Drill Tower, Standard/Lateral (25mm); ... | Feb 11, 2026 |
| Z-1651-2026 | Class II | Embrace Drill Tower, Wedged (25mm); Item Numbe... | Feb 11, 2026 |
| Z-1511-2026 | Class II | Endo-Model SL Connection Component incl. PE-Pla... | Jan 12, 2026 |
| Z-1521-2026 | Class II | Endo-Model Replacement Plateau; Item Number: 1... | Jan 12, 2026 |
| Z-1512-2026 | Class II | Endo-Model Replacement Plateau; Item Number: 1... | Jan 12, 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.