FDA-Device2026-03-18Class II

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;

Waldemar Link GmbH & Co. KG (Mfg Site)

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

49 units (OUS only)

Manufactured in

Ost Str. 4-10, N/A, Norderstedt, N/A, Germany

Products

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1513-2026

Original summary

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02; The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. 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; 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. Affected quantity: 49 units (OUS only)

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