Class II recallOngoing

Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, recall — FDA event 97971

FDA · FDA event 97971 · Posted Dec 9, 2025

Published Dec 9, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

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.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

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 complaints@linkbio.com for any questions.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, by Waldemar Link GmbH & Co. KG (Mfg Site).

Products affected by FDA event 97971
Model	Description	Lot / serial range	Manufactured	Status
Z-0890-2026	Z-0890-2026	Item Number: 15-0028/08; UDI-DI: 04026575175222; Lot Number: 2535004;	Not provided in the normalized record	Ongoing

Distribution: US distribution to states of: AL, GA, and TX.
Units affected: See official FDA record
Category: Knee implants

Timeline

Nov 10, 2025
Recall initiated
Date recorded by the FDA.
Dec 9, 2025
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 97971
Published: Dec 9, 2025
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

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Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, recall — FDA event 97971

FDA · FDA event 97971 · Posted Dec 9, 2025

Published Dec 9, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Affected products and models

This FDA record lists Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, by Waldemar Link GmbH & Co. KG (Mfg Site).

Products affected by FDA event 97971
Model	Description	Lot / serial range	Manufactured	Status
Z-0890-2026	Z-0890-2026	Item Number: 15-0028/08; UDI-DI: 04026575175222; Lot Number: 2535004;	Not provided in the normalized record	Ongoing

Distribution

US distribution to states of: AL, GA, and TX.

Units affected

See official FDA record

EMPOWR 3D KNEE INS, 11L 14MM, VE recall — FDA event 98700

Due to packaging discrepancy with incorrect product size mixed up.

FDA · FDA event 98700Posted Jul 8, 2026

Class II recallOngoing

Persona Revision Trabecular Metal Femoral Distal Augment recall — FDA event 99073

Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.

FDA · FDA event 99073Posted Jun 24, 2026

Class II recallOngoing

TRI TS BASEPLATE SIZE 3 recall — FDA event 99080

FDA · FDA event 99080Posted Jun 17, 2026

Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, recall — FDA event 97971

Follow Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component,

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, recall — FDA event 97971

Follow Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component,

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline