Endo-Model SL Connection Component incl. PE-Plateau recall (Waldemar Link GmbH & Co. KG (Mfg Site))
Medical deviceClass IIOngoing
Summary: Waldemar Link GmbH & Co. KG (Mfg Site) is recalling Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;. Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
What is being recalled
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
Why
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: New Jersey)
How to tell if yours is affected
Item Number: 16-2840/02; UDI-DI: 04026575359233; Serial/Lot Number: 250925/0640 , 250925/0641, 250925/0642, 250925/0646, 250925/0650, 250925/0652, 250925/0653 , 250925/0656, 250925/0658, 250925/0669, 250925/0670, 250925/0680, 250925/0681 , 250925/0682, 250925/0687, 250925/0689, 250925/0690, 250925/0691, 250925/0693 , 250925/0694, 251110/3293, 250925/0660, 250925/0661, 250925/0684, 250925/0685 , 250925/0657, 250925/0663, 250925/0659, 250925/0678, 251110/3288, 251110/3292 , 251110/3303, 251110/3313, 250925/0683, 250925/0674, 250925/0644, 250925/0665 , 250925/0668, 250925/0671, 250925/0673, 250925/0676, 250925/0664 , 250925/0651 , 251110/3297, 251110/3289, 250925/0639, 250925/0648, 250925/0688, 250925/0696;
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1513-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | January 12, 2026 |
| Reported | March 18, 2026 |
| Company | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Company location | Norderstedt, N/A, Germany |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 49 units (OUS only) |
More recalls from Waldemar Link GmbH & Co. KG (Mfg Site) · all medical device recalls · recalls from January 2026