LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with Mobilit...

FDA Device Recall #Z-2354-2023 — Class II — July 3, 2023

Recall Summary

Recall Number Z-2354-2023
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 23 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-23/00

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: 04026575182176 Lot Numbers: B922118 B933169 C005023 C211017 C240048

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.