United StatesEndo-Model SL Connection Component including PE-Plateau and multiple Endo-Model Replacement Plateau implants (examples of affected item numbers include 16-2840/05, 16-2840/02, 16-2840/07 and 15-0027/15, among others and associated UDI-DIs and serial/lot numbers) are included in this recall. They were recalled because a plateau screw bushing could detach from the screw shaft due to a longitudinal fracture.
What's being recalled
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
Endo-Model Replacement Plateau; Item Number: 15-0027/15;
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
Endo-Model Replacement Plateau; Item Number: 15-2835/12;
Endo-Model Replacement Plateau; Item Number: 15-2836/11;
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
Endo-Model Replacement Plateau; Item Number: 15-8521/09;
Endo-Model Replacement Plateau; Item Number: 15-8521/11;
Endo-Model Replacement Plateau; Item Number: 15-8521/15;
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
Endo-Model Replacement Plateau; Item Number: 15-0027/12;
Endo-Model Replacement Plateau; Item Number: 15-0027/16;
Recalling firm: Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt, N/A, Germany.
How to identify it
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; Item Number: 15-0027/15; UDI-DI: 04026575432127; Serial/Lot Number: 2549190; 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; 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; Item Number: 15-2835/12; UDI-DI: 04026575316564; Serial/Lot Number: 241210/1809…
The hazard
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)