Waldemar Link Class II Device Recall Z-1511-2026
Summary
The FDA has issued a Class II device recall (Z-1511-2026) for Waldemar Link's Endo-Model SL Connection Component due to the potential for a plateau screw's bushing to detach. The recall is ongoing and has seen worldwide distribution, including nationwide in the US.
What changed
The FDA has initiated a Class II device recall, identified as Z-1511-2026, for Waldemar Link GmbH & Co. KG's Endo-Model SL Connection Component (Item Number: 16-2840/05). The recall is due to a defect where the bushing of an implant with a plateau screw could detach from the screw shaft due to a longitudinal fracture, posing a potential risk.
This recall is ongoing and has been distributed worldwide, including within the United States (NJ) and several other countries. Companies that may have received this product should review their inventory and consult with Waldemar Link for specific instructions regarding the recall process and potential remediation steps. While no specific compliance deadline is listed, prompt action is advised given the nature of the defect.
What to do next
- Review inventory for Waldemar Link Endo-Model SL Connection Component (Item Number: 16-2840/05)
- Contact Waldemar Link for specific recall instructions and remediation procedures
Source document (simplified)
Waldemar Link GmbH & Co. KG (Mfg Site)
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1511-2026 · 20260318 · Ongoing
Product
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
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 Kin...
Source: openFDA Enforcement API
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