FDA-Device2026-03-18Class IIPROCESSING DEFECT
Waldemar Link Endo-Model SL Connection Component recalled for potential bushing detachment
OTHERNationwide distribution
Stop using affected Waldemar Link implant components
Waldemar Link GmbH & Co. KG is recalling specific lots of the Endo-Model SL Connection Component (Item 16-2840/05) used in orthopedic implants. A bushing on the plateau screw could detach from the screw shaft due to a crack, which could affect implant stability. One unit was distributed in the U.S. (New Jersey); the remaining 43 units were distributed internationally.
- Contact your surgeon or healthcare provider immediately if you received this implant component
- Check the lot number on your implant documentation against the FDA recall list
- Do not use any inventory of this component if you are a healthcare facility
- Report any problems with your implant to the FDA MedWatch program
Hazard
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Sold states
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.
Affected count
44 units (1 US, 43 OUS)
Manufactured in
Ost Str. 4-10, N/A, Norderstedt, N/A, Germany
Products
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1511-2026More Waldemar Link GmbH & Co. KG (Mfg Site) recalls
- FDA-Device2026-04-01Waldemar Link Embrace Drill Tower recalled for incorrect article numbers in surgical guide
- FDA-Device2026-04-01Waldemar Link Embrace Drill Tower surgical instructions contain incorrect article numbers
- FDA-Device2026-03-18Waldemar Link Endo-Model Replacement Plateau recalled for potential bushing detachment
- FDA-Device2026-03-18Waldemar Link Endo-Model Replacement Plateau screw recalled for detaching bushing
- FDA-Device2026-03-18Waldemar Link Endo-Model Replacement Plateau screw recalled for potential bushing detachment
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