Recall of LinkSymphoKnee Distal Femoral Augment (Size 7-8) due to risk of improper screw insertion causing potential complications. Affected units include specific product codes and lot numbers.
Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
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Contact the company
📍Recalling firmWaldemar Link GmbH & Co. KG (Mfg Site)Oststr. 4-10 · Norderstedt, Germany
✎ GovInfoNow plain-language explainer
Waldemar Link is recalling certain LinkSymphoKnee Distal Femoral Augments (Size 7-8) because the fixation screw may be inserted through the wrong side of the augment. This could lead to improper alignment and potential complications after surgery. Read more at govinfonow.com/recall/59055-linksymphoknee-augment-wrong-screw-insertion-risk.
“LinkSymphoKnee Augment: Wrong Screw Insertion Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59055-linksymphoknee-augment-wrong-screw-insertion-risk. Based on FDA recall #Z-2067-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2067-2023%22&limit=1).
Waldemar Link GmbH & Co. KG recalled one lot of LinkSymphoKnee Distal Femoral Augments on Dec. 23, 2022, because fixation screws were inserted through the wrong side of the augment, according to the FDA.
The hazard is that the fixation screw was inserted through the wrong side of the augment, specifically distal to proximal rather than the correct proximal to distal orientation.
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 Medartis APTUS Screws (April 24, 2026), U2 Total Knee System Femoral Offset Bushing Recall (March 19, 2026), and Straumann Dental Implant Abutments Recall (March 27, 2026).
How to tell if you have this one
Check for the product code 880-307/21 and lot number 2123233 on the packaging. The augment is intended for primary and revision total knee replacements in skeletally mature patients.
Brand
Waldem:Link
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.
Recall number
Product, codes & lots
Z-2066-2023
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/11; UDI-DI: 04026575257379 Lot Number: 2123225
Z-2067-2023
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/21; UDI-DI: 04026575257393 Lot Number: 2123233
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product code 880-307/21 and lot number 2123233 on the packaging to confirm if the item is recalled.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Georgia, Illinois, Indiana, Louisiana, Nevada, Texas.
Recall timeline
FDA published this recall 7 months 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 recall indicates a potential risk of improper screw insertion, so affected units should be checked and handled according to the recall instructions.
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-2067-2023 (December 23, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2067-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.