Knee Implant Recall: Waldemar Link LinkSymphoKnee Tibial
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect. Eight units were distributed worldwide, including US states CO, IN, NJ, TX and in Germany and Italy. Recall number 880-100/50; Serial Numbers: 210125/2259, 210125/2262, 210125/2268, 210125/2260, 210125/2264, 210125/2270, 210125/2272, 210125/2273.
| Brand | Waldemar Link GmbH & Co. KG (Mfg Site) |
|---|---|
| Product | LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50 |
| Reason | Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect. |
| Severity | moderate |
| Units affected | 75 |
| Distribution | Worldwide - US Nationwide distribution in the states of CO, IN, NJ, TX and the countries of Germany and Italy. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Contact your orthopedic surgeon to determine if your implanted component is affected and provide serial/REF numbers if available.
- Do not attempt to modify or remove the implant yourself; follow your surgeon's instructions for evaluation or treatment.
- If advised, schedule an evaluation or corrective action with your implant center.
- Refer to the FDA recall notice and manufacturer's guidance for the latest information.
How to identify the recalled item
| Lot / date codes | REF Number: 880-100/50. UDI-DI: 04026575251278. Serial Numbers: 210125/2259, 210125/2262, 210125/2268, 210125/2260, 210125/2264, 210125/2270, 210125/2272, 210125/2273. |
|---|---|
| Lot / date codes | Item Number: Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots; |
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 knee implant 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.