Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;

Published: March 18, 2026Recall ID: Z-1514-2026Category: devicesCountry: US

Reason for Recall / Hazard

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;

Field	Value
City	Norderstedt
State	N/A
Event id	98342
Address 1	Ost Str. 4-10
Address 2	N/A
Code info	Item Number: 16-2840/07; UDI-DI: 04026575359257; Serial/Lot Number: 250925/0480 , 250925/0481, 250925/0482, 250925/0483, 250925/0484, 250925/0486, 250925/0489 , 250925/0491, 250925/0492, 250925/0494, 250925/0503, 250925/0504, 250925/0345 , 250925/0346, 250925/0349, 250925/0350, 250925/0351, 250925/0352, 250925/0356 , 250925/0369, 250925/0501, 250925/0365, 250925/0368, 250925/0490, 250925/0488 , 250925/0479, 250925/0495, 250925/0500, 250925/0496, 250925/0499, 250925/0367;
Postal code	N/A
Report date	20260318
Product type	Devices
Product quantity	31 units (OUS only)
Reason for recall	The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Voluntary mandated	Voluntary: Firm initiated
Recall initiation date	20260112
Initial firm notification	Letter
Center classification date	20260310

Recalling FirmWaldemar Link GmbH & Co. KG (Mfg Site)
StatusOngoing
Risk LevelClass II
DistributionWorldwide - 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.