Use cautionMedical device recall · FDA · Published December 7, 2018
Waldemar Link LINK STEM Prosthesis Recall: Incorrect Fit Risk
Waldemar Link recalls certain LINK STEM prosthesis models due to potential incorrect neck fit causing improper joint alignment. Affected units have specific lot numbers and sizes.
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.
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Contact the company
📍Recalling firmWaldemar Link GmbH & Co. KG (Mfg Site)Oststr. 4-10 · Norderstedt, Germany
“Waldemar Link LINK STEM Prosthesis Recall: Incorrect Fit Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/69368-waldemar-link-link-stem-prosthesis-recall-incorrect-fit-risk. Based on FDA recall #Z-0733-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0733-2019%22&limit=1).
Waldemar Link GmbH & Co. KG recalled LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0) on Dec. 7, 2018, according to the FDA. The device's reaming guide and guide rod may not screw into the intended depth due to a reduced core hole in the stem.
How to tell if you have it
Brand: Waldemar Link
Product: LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm)
Reference Number: 172-916/12
Lot numbers: 1435077, 1515029, 1718103, 150401/0217, 1734168, 1726056
Distribution: US Nationwide in FL, GA, IA, IN, KS, MI, MN, and TN
The hazard
The FDA stated that a reaming guide not screwed in completely may lead to insufficient proximal preparation depth and incorrect neck positioning. The correct fit of the neck cannot be verified by means of the guide rod.
Context
GovInfoNow's records show Waldemar Link GmbH & Co. KG has 21 other recalls on record since Dec. 4, 2018. Other recent recalls of similar products include Waldemar Link Endo-Model Tibial Plateau Recall (July 6, 2026), Embrace Drill Tower Recall (Feb. 11, 2026), and Waldemar Link Endo-Model Plateau Recall (Jan. 12, 2026). Other recent recalls of similar products include Straumann Dental Implant Abutments Recall (March 27, 2026), U2 Total Knee System Femoral Offset Bushing Recall (March 19, 2026), and Straumann GM Helix Dental Implant Recall (July 13, 2026).
How to tell if you have this one
Check for the product name 'LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS' with size XS-0 (12mm diameter, 160mm length). Affected units have specific lot numbers listed in the recall.
Brand
Waldemar Link
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product size (XS-0, 12mm diameter, 160mm length) and lot numbers from the recall list.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 8 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide in the states of: FL, GA, IA, IN, KS, MI, MN, and TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Georgia, Indiana, Iowa, Kansas, Michigan, Minnesota, Tennessee.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0733-2019 (December 7, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0733-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.