Z-2289-2025Class II

Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15

Name: Z-2289-2025 Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15
Creator: Waldemar Link GmbH & Co. KG (Mfg Site)
Published: 2025-07-15
License: https://open.fda.gov/license/

Waldemar Link GmbH & Co. KG / initiated 2025-07-15 / Open, Classified / root cause: labeling and UDI

FDA source

Waldemar Link GmbH & Co. KG (Mfg Site) began a recall of Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15 on 2025-07-15. FDA classified it as Class II and gives the reason as "Inconsistent size terminology and color coding used on labeling". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2289-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-15
Posted: 2025-08-11
Recalling firm: Waldemar Link GmbH & Co. KG
Product: Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
Product code: JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
Reason for recall: Inconsistent size terminology and color coding used on labeling
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Waldemar Link GmbH & Co. notified consignees of the recall via email on about 07/15/2025. Consignees were instructed to respond using the Distributor Reply form and arrange for the return of all affected product on hand.
Quantity in commerce: 17 units
Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IN, KS, LA, NJ and the countries of Germany, Argentina, Belgium, Switzerland, Cyprus, Algeria, Finland, Hungary, Mexico, Netherlands, Peru, Slovenia, and Uruguay.
Product codes and lots: Item Number: 175-928/15. UDI-DI: 04026575150700. Serial Numbers: C126168, C424053

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2289-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2288-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-11
Z-2289-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-11

Product code JDG

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)