Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
LINK STEM with Microporous Surface MP Reconstruction Prosthesis Recalled by Waldemar Link GmbH & Co. KG (Mfg Site) Due to The reaming guide and the guide rod can't...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Waldemar Link GmbH & Co. KG (Mfg Site) directly.
Affected Products
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.
Quantity: 11
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Waldemar Link GmbH & Co. KG (Mfg Site)
Waldemar Link GmbH & Co. KG (Mfg Site) has 62 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report