Z-2046-2023Class II

LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right

Name: Z-2046-2023 LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right
Creator: Waldemar Link GmbH & Co. KG (Mfg Site)
Published: 2021-03-18
License: https://open.fda.gov/license/

Waldemar Link GmbH & Co. KG / initiated 2021-03-18 / Open, Classified / root cause: design

FDA source

Waldemar Link GmbH & Co. KG (Mfg Site) began a recall of LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right on 2021-03-18. FDA classified it as Class II and gives the reason as "The firm discovered through customer complaints that device segments may not meet specifications". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2046-2023
Classification: Class II
Status: Open, Classified
Initiated: 2021-03-18
Posted: 2023-06-30
Recalling firm: Waldemar Link GmbH & Co. KG
Product: LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Reason for recall: The firm discovered through customer complaints that device segments may not meet specifications.
Root cause tag: design
FDA root cause: Device Design
Action: The firm sent recall notifications by email to consignees on 03/24/2021. Customers were asked to discontinue use of affected devices and to return any that remain in stock to LinkBio Corporation, Waldemar Link's US Distributor, immediately. Credit or replacement was issued for the returned product upon receipt. Any questions about this recall event are to be directed to Nikhil Mangale at 1-973-625-1333 ext. 116 from Monday through Friday from 8:00 am to 5:30 pm, or by email to [email protected].
Quantity in commerce: 21 units
Distribution: Domestic: AL, GA, IL, IN, KS, NJ, NY, and TX. Foreign: Argentina, Australia, Austria, Brazil, Finland, France, Germany, India, Italy, Spain, and United Kingdom.
Product codes and lots: Item No. 15-2973/05; UDI-DI: 04026575340699.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2046-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2046-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-30
Z-2047-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-30
Z-2048-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-30
Z-2049-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-30

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)