FDAFDA recall Z-2934-2026 · Aug 19, 2026
Waldemar Link GmbH & Co. KG (Mfg Site): Endo-Model recall
Recall found
Product
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069
- Quantity
- 1 US; 9 OUS
- Distribution
- Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-06
Source: openFDA enforcement record Z-2934-2026 · search recall number Z-2934-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.