Class II recallOngoing

Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16 recall — FDA event 99405

FDA · FDA event 99405 · FDA posted Aug 11, 2026

Published by MedWatcher Oct 28, 2026Record source last checked: 2026-10-28 03:25:03 UTC

What happened

The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.

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

Foreign manufacturer, Waldemar Link GmbH & Co KG, notified importer LinkBio Corp. on 7/6/2026 via email. LinkBio then notified the single US consignee by email/Docusign on 7/7/2026.
Customer was instructed to return the affected product to LinkBio.

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, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16 by Waldemar Link GmbH & Co. KG (Mfg Site).

Products affected by FDA event 99405
Model	Description	Lot / serial range	Manufactured	Status
Z-2934-2026	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16	UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069	Not provided in the normalized record	Ongoing

Distribution: Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
Units affected: See official FDA record
Category: Knee implants

Timeline

Jul 6, 2026
Recall initiated
Date recorded by the FDA.
Aug 11, 2026
Posted by FDA
The recall event appeared in the FDA source.
Oct 28, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 99405
Published: Aug 11, 2026
Source checked: 2026-10-28 03:25:03 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, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16 recall — FDA event 99405

FDA · FDA event 99405 · FDA posted Aug 11, 2026

Published by MedWatcher Oct 28, 2026Record source last checked: 2026-10-28 03:25:03 UTC

What happened

Affected products and models

This FDA record lists Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16 by Waldemar Link GmbH & Co. KG (Mfg Site).

Products affected by FDA event 99405
Model	Description	Lot / serial range	Manufactured	Status
Z-2934-2026	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16	UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069	Not provided in the normalized record	Ongoing

Distribution

Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.

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, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16 recall — FDA event 99405

Follow Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16 recall — FDA event 99405

Follow Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16

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