Class II — Waldemar Link GmbH & Co. KG (Mfg Site)
| Recalling firm | WALDEMAR LINK GMBH & CO. KG |
|---|---|
| Registered facility | Waldemar Link GmbH & Co. KG (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. |
| Product | Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07; |
| Quantity | 31 units (OUS only) |
| 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. |
| Initiated | 2026-01-12 |
| Classified | 2026-03-10 |
| Recall number | Z-1514-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Waldemar Link GmbH & Co. KG (Mfg Site) (Z-1514-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98342/
Alerts for WALDEMAR LINK GMBH & CO. KG
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.