Waldemar Link Endo-Model tibial plateau recalled for wrong part
Some Endo-Model replacement sets for a Rotating Hinge tibial plateau were packaged with a Pure Hinge plateau instead. The wrong plateau cannot be inserted, which could make surgery longer or require a different product. If it were implanted, it could wear faster and shorten how long the implant lasts. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Waldemar Link recalls
What to do
- Check item number 15-0027/16 and lot 2604069 (UDI 04026575432134) against any replacement sets in stock.
- Do not use affected sets. Set them aside and keep them for return.
- Contact Waldemar Link or your supplier for instructions on return and replacement.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
- Sold in
- Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
- Made for
- Adults (0 months and older)
Details
- Units affected
- 1 US; 9 OUS
- Illnesses reported
- None reported
- Manufactured in
- Ost Str. 4-10, Norderstedt, Germany
- Classification
- Class II
- Recall number
- Z-2934-2026
In the FDA's words
- Description
- Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16 The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant. UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069 Distribution: Domestic US distribution to Indiana. OUS distribution to Belarus and Germany. Affected quantity: 1 US; 9 OUS
- Hazard
- The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.