Z-2934-2026 Class II Ongoing
FDA device recall Z-2934-2026 was initiated by Waldemar Link GmbH & Co. KG (Mfg Site) on July 6, 2026 and is designated Class II. Reason for recall: 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 platea… The recall status is ongoing. Affected quantity: 1 US; 9 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- August 19, 2026
- Initiation Date
- July 6, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 US; 9 OUS
Product Description
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
Reason for Recall
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.
Distribution Pattern
Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
Code Information
UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069