Waldemar Link GmbH & Co. KG (Mfg Site): Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Product
- Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
- Reason / hazard
- The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2026-01-12
- 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;
- Product quantity
- 31 units (OUS only)
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Norderstedt
- State
- N/A
- Country
- Germany
- Event id
- 98342
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