Z-2934-2026Class II

Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number...

Name: Z-2934-2026 Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number...
Creator: Waldemar Link GmbH & Co. KG (Mfg Site)
Published: 2026-07-06
License: https://open.fda.gov/license/

Waldemar Link GmbH & Co. KG / initiated 2026-07-06 / Open, Classified

FDA source

Waldemar Link GmbH & Co. KG (Mfg Site) began a recall of Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16 on 2026-07-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2934-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-06
Posted: 2026-08-11
Recalling firm: Waldemar Link GmbH & Co. KG
Product: Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Reason for recall: 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.
FDA root cause: Process change control
Action: 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.
Quantity in commerce: 1 US; 9 OUS
Distribution: Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
Product codes and lots: UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2934-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2934-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-19	2026-08-11

Product code KRO

K143179Class IIThe LINK® Endo-Model® Knee SystemWaldemar Link GmbH & Co. KG / cleared 2015-01-30

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)