Waldemar Link GmbH & Co. KG (Mfg Site): Medical Device Recall in 2026 - (Recall #: Z-1518-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

Endo-Model Replacement Plateau; Item Number: 15-8521/09;

Product Classification:

Class II

Date Initiated: January 12, 2026

Date Posted: March 18, 2026

Recall Number: Z-1518-2026

Event ID: 98342

Reason for Recall:

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Status: Ongoing

Product Quantity: 8 units (OUS only)

Code Information:

Item Number: 15-8521/09; UDI-DI: 04026575383238; Serial/Lot Number: 250728/0038, 250728/0039, 250728/0040, 250728/0041, 250728/0042, 250728/0043, 250728/0044, 250728/0045;

Distribution Pattern:

Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.

Voluntary or Mandated:

Voluntary: Firm initiated