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: 16-2840/05;. 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: 16-2840/05;
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: 16-2840/05; UDI-DI: 04026575359240; Serial/Lot Number: 250513/2083, 250513/2085 , 250513/2086, 250513/2089, 250513/2090, 250513/2092, 250513/2093, 250513/2097 , 250513/2100, 250513/2102, 250513/2104, 250513/2107, 250513/2108, 251013/3245 , 251013/3247, 251013/3250, 251013/3251, 251013/3252, 251013/3253, 251105/0013 , 251105/0016, 251105/0018, 251105/0020, 251105/0032, 251105/0034, 251105/0036 , 251105/0037, 251105/0038, 251105/0039, 250513/2106, 250513/2099, 251105/0014 , 251105/0040, 251105/0002, 250513/2087, 250513/2091, 251013/3246, 251105/0019 , 251013/3249, 251105/0011, 251105/0012, 250513/2103, 250513/2105, 251013/3254;
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-1511-2026 |
| 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 | 44 units (1 US, 43 OUS) |
More recalls from Waldemar Link GmbH & Co. KG (Mfg Site) · all medical device recalls · recalls from January 2026