Lower riskMedical device recall · FDA · Published December 5, 2024
Waldemar Link LINK MP Neck Segment Recall: Label Error Causes Size Misidentification
Waldemar Link recalls specific neck segments due to label error showing size XXL instead of standard. All other details correct. Affected patients should verify product details to avoid incorrect use.
Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).
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📍Recalling firmWaldemar Link GmbH & Co. KG (Mfg Site)Oststr. 4-10 · Norderstedt, Germany
✎ GovInfoNow plain-language explainer
Waldemar Link is recalling certain neck segments for hip reconstruction because the labels incorrectly show a size XXL when they are standard size. This could lead to improper use if the wrong size is selected. The recall does not involve safety risks beyond labeling confusion. Read more at govinfonow.com/recall/53329-waldemar-link-link-mp-neck-segment-recall-label-error-causes.
“Waldemar Link LINK MP Neck Segment Recall: Label Error Causes Size Misidentification.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53329-waldemar-link-link-mp-neck-segment-recall-label-error-causes. Based on FDA recall #Z-0769-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0769-2025%22&limit=1).
The FDA announced on Dec. 5, 2024, that Waldemar Link GmbH & Co. KG is recalling LINK MP Reconstruction System Neck Segments due to labeling errors indicating a size XXL for standard-size units. The agency issued recall number Z-0769-2025 for the Class II device.
How to tell if you have it
Brand: Waldemar Link
Product: LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm)
GovInfoNow's records show the hazard involves errors on the main label and patient label that indicate a size XXL for a standard-size neck segment. All other information on the labels, including length, CCD, and offset, remains correct.
Context
GovInfoNow's records show Waldemar Link GmbH & Co. KG has 21 other recalls on record since 2018-12-04. Other recent recalls of similar products include Waldemar Link Endo-Model Tibial Plateau Recall (2026-07-06), Embrace Drill Tower Wedged (25mm) Recall (2026-02-11), and Waldemar Link Endo-Model Plateau Recall (2026-01-12). Other recent recalls of similar products include Smith & Nephew BIOSURE HA Screw Recall (2025-11-24), Grace Medical recalls Stapes Prosthesis due to incorrect labeling (2026-04-03), and Tornier Perip Screw Recall (2025-12-19).
How to tell if you have this one
Check for the specific model: LINK MP Neck Segment (with suture holes, standard, uncemented, L=35 mm, CCD 126°, Offset=31 mm). Look for serial numbers in the list provided in the recall notice.
Brand
Waldemar Link
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Verify Product Details
Check the product's serial number against the list provided in the recall notice to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AL, FL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Florida.
Recall timeline
FDA published this recall 27 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-0769-2025 (December 5, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0769-2025 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.