Z-0890-2026Class II

Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12...

Name: Z-0890-2026 Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12...
Creator: Waldemar Link GmbH & Co. KG (Mfg Site)
Published: 2025-11-10
License: https://open.fda.gov/license/

Waldemar Link GmbH & Co. KG / initiated 2025-11-10 / Open, Classified / root cause: manufacturing process

FDA source

Waldemar Link GmbH & Co. KG (Mfg Site) began a recall of 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 on 2025-11-10. FDA classified it as Class II and gives the reason 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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0890-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-10
Posted: 2025-12-09
Recalling firm: Waldemar Link GmbH & Co. KG
Product: 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.
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On November 10, 2025, URGENT: MEDICAL DEVICE RECALL letters were emailed to distributors. Actions to be taken: Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return the affected product. Please return the product as soon as possible to the following address: LinkBio Corporation 69 King St Dover, NJ 07801 Please contact LinkBio at 973-625-1333 or [email protected] for any questions.
Quantity in commerce: 18 units
Distribution: US distribution to states of: AL, GA, and TX.
Product codes and lots: Item Number: 15-0028/08; UDI-DI: 04026575175222; Lot Number: 2535004;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0890-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0890-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-17	2025-12-09

Product code KRO

K151008Class IILink® Megasystem-C®Waldemar Link GmbH & Co. KG / cleared 2015-08-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)