- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- 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.
- Affected products (lot / model / serial)
- UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069
- Units affected
- 1 US; 9 OUS
- Distribution pattern
- Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
- Firm location
- Norderstedt, Germany
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2934-2026
- Recall initiated
- July 6, 2026
- FDA classification date
- August 11, 2026
- FDA report date
- August 19, 2026
- FDA event ID
- 99405
- Last updated on HTM Vibe
- August 26, 2026