LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, ...
FDA Device Recall #Z-0733-2019 — Class II — December 7, 2018
Recall Summary
| Recall Number | Z-0733-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 7, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Location | Norderstedt |
| Product Type | Devices |
| Quantity | 11 |
Product Description
LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Product Usage: The LINK¿ STEM with Microporous Surface MP¿ Reconstruction Prosthesis, CEMENTLESS System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The LINK¿ STEM with Microporous Surface MP¿ Reconstruction Prosthesis, CEMENTLESS System is indicated for the following conditions: Revision arthroplasty due to juxta-articular bone defects Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone Revision of loosened femoral prosthesis components with periprosthetic/subprosthetic fracture Deformed proximal femur due to fractures or osteotomies Correction of bone deficiencies, e.g. due to tumors Large post-revision and post-trauma segmental bone defects Oncological and revision surgery from tibial to hip area (in conjunction with Endo-Model¿ SL Rotational and Hinge Knee Prostheses) The device is intended for cemented and cementless use.
Reason for Recall
The reaming guide and the guide rod can't be screwed into the intended depth. The reason for this is a reduced depth of the core hole in the stem. A reaming guide that is not screwed in completely may lead to a proximal preparation in the depth that is not sufficient and to a neck that can't be positioned correctly. The correct fit of the neck can't be verified by means of the guide rod.
Distribution Pattern
US Nationwide in the states of: FL, GA, IA, IN, KS, MI, MN, and TN.
Lot / Code Information
Lot numbers: 1435077 1515029 1718103 1435077 150401/0217 1734168 1726056 1718103 1734168 1515029
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.