Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
FDA device recall Z-2934-2026 · posted 2026-08-11 · Open, Classified
Recall details
- 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.
- Action taken
- Foreign manufacturer, Waldemar Link GmbH & Co KG, notified importer LinkBio Corp. on 7/6/2026 via email. LinkBio then notified the single US consignee by email/Docusign on 7/7/2026. Customer was instructed to return the affected product to LinkBio.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- KRO
- Quantity affected
- 1 US; 9 OUS
- Distribution
- Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
- Date initiated
- 2026-07-06
- Date posted
- 2026-08-11
- Location
- Norderstedt, Germany
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| The LINK® Endo-Model® Knee System (K143179) | Waldemar Link GmbH & Co. KG | 2015-01-30 |