Z-1518-2026Class II

Waldemar Link GmbH & Co. KG (Mfg Site)

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Device

Status

Ongoing

Report date

2026-03-18

Distribution

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.

Firm state

N/A

Product quantity

8 units (OUS only)

Initiated by

Voluntary: Firm initiated

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.

Product description

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

Code / lot info

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;

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →