Waldemar Link Endo-Model Tibial Plateau Replacement Set Recall
The 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 implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.
| Brand | Waldemar Link GmbH & Co. KG (Mfg Site) |
|---|---|
| Product | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16 |
| Reason | 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. |
| Severity | moderate |
| Units affected | 1 |
| Distribution | Domestic US distribution to Indiana. OUS distribution to Belarus and Germany. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use or implant the affected Endo-Model tibial plateau replacement set; contact your surgeon or hospital to discuss replacement options.
- If your procedure has not yet occurred, arrange for the correct Rotating Hinge tibial plateau replacement set and do not proceed with the incorrect plate.
- If the incorrect plateau has already been implanted, schedule a follow-up with your surgeon to monitor for wear and potential implant issues.
- Keep the recall information (brand/product, recall number and lot) and follow the instructions provided by your healthcare provider or the facility for replacement.
How to identify the recalled item
| Lot / date codes | UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069 |
|---|---|
| Lot / date codes | UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other Waldemar Link GmbH & Co. KG (Mfg Site) recalls
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.