Endo-Model Replacement Plateau; Item Number: 15-8521/09;
Summary
The FDA issued a Class II for Endo-Model Replacement Plateau; Item Number: 15-8521/09; by Waldemar Link GmbH & Co. KG (Mfg Site). Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture..
Details
Source
Device Recall
External ID
Z-1518-2026
Action Date
2026-03-18
Status
Ongoing
Category
device
Product Description
Endo-Model Replacement Plateau; Item Number: 15-8521/09;
Lot/Code 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;
Quantity Affected: 8 units (OUS only)
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-12
Company
Norderstedt, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 190 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Waldemar Link GmbH & Co. KG (Mfg Site) has 61 FDA actions in our database, including 61 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Waldemar Link GmbH & Co. KG (Mfg Site)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Waldemar Link GmbH & Co. KG (Mfg Site) have FDA actions?
Waldemar Link GmbH & Co. KG (Mfg Site) has 61 FDA actions in our database, including 61 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1518-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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