Food, drugs, devices › Waldemar Link GmbH & Co. KG (Mfg Site)
Device recall: Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee compon
Waldemar Link GmbH & Co. KG (Mfg Site) (Norderstedt, N/A) initiated this device recall on 10 Nov 2025; FDA lists 1 product record under event 97971, classified Class II.
FDA defines Class II as 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. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Waldemar Link GmbH & Co. KG (Mfg Site) has 22 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt, N/A, Germany.
Reason for recall
"The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component."
Distribution
"US distribution to states of: AL, GA, and TX."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0890-2026 | Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices. | 18 units | Class II | Ongoing | 17 Dec 2025 |
Context
Other enforcement events for Waldemar Link GmbH & Co. KG (Mfg Site)
All 22 events for Waldemar Link GmbH & Co. KG (Mfg Site)
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US distribution to states of: AL, GA, and TX."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.