Waldemar Link LINK STEM Reconstruction Prosthesis Recalled for Depth Defect
Waldemar Link is recalling 11 LINK STEM Reconstruction Prostheses because a manufacturing defect prevents the reaming guide from reaching the intended depth, which may lead to incorrect surgical positioning.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect poses a risk of improper surgical positioning and insufficient bone preparation, which constitutes a risk of harm where injury has not yet been reported.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling 11 units of the LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12. The recall covers specific lot numbers including 1435077, 1515029, 1718103, 150401/0217, 1734168, and 1726056. The affected devices were distributed in the United States in the states of Florida, Georgia, Iowa, Indiana, Kansas, Michigan, Minnesota, and Tennessee.
The recall is due to a manufacturing defect where the core hole in the stem has a reduced depth. This defect prevents the reaming guide and guide rod from being screwed into the intended depth. If the reaming guide is not screwed in completely, it may result in a proximal preparation that is not sufficient in depth and a neck that cannot be positioned correctly. Additionally, the correct fit of the neck cannot be verified by means of the guide rod.
Healthcare providers and patients should contact Waldemar Link for instructions on how to return the affected devices. The device is indicated for revision arthroplasty and other complex orthopedic procedures involving bone defects or fractures.
The recalled product
- Product
- 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…
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Affected units
- 11
Distribution
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