Waldemar Link Recalls Endo-Model Tibial Plateau Replacement Sets
Waldemar Link is recalling Endo-Model tibial plateau replacement sets that incorrectly contain a Pure Hinge plateau, posing a risk of increased wear if implanted.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (increased wear and reduced implant standing time) where no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling specific Endo-Model replacement sets for a Rotating Hinge tibial plateau. The affected units, identified by UDI-DI 04026575432134 and Lot 2604069, incorrectly contain a Pure Hinge plateau instead of the intended component. The recall involves one unit distributed domestically to Indiana and nine units distributed to Belarus and Germany.
The incorrect plateau cannot be inserted as intended, which could lead to a prolonged or modified surgery requiring an alternative product. If the incorrect plateau were implanted, it is associated with an increased risk of wear, which could result in a reduced standing time of the implant.
Healthcare providers and patients should check their inventory and records for the specific item number 15-0027/16 and lot number 2604069. If the affected product is found, it should be removed from use and returned to the manufacturer or distributor according to their instructions.
The recalled product
- Product
- Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069
Distribution
Distributed in 1 state:
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