LinkSymphoKnee Tibial Component Recalled Due to Uncoated Security Screws
Waldemar Link is recalling 8 LinkSymphoKnee knee prosthetic components manufactured with uncoated security screws instead of coated screws. Uncoated screws in the implant present a risk of corrosion and potential implant failure.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a manufacturing defect in an orthopedic implant. Uncoated security screws in a weight-bearing knee prosthetic component present a risk of corrosion and implant failure. No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet been reported, warranting a High severity rating per the rubric.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling certain LinkSymphoKnee System Tibial Components (Modular, Symmetric, Size 5, CoCrMo/TiNbN, cemented). The recalled components are identified by REF Number 880-100/50.
Some of the recalled components were manufactured with two uncoated security screws instead of coated screws. In a weight-bearing knee prosthetic, uncoated metal screws present a risk of corrosion and potential implant failure.
A total of 8 units were manufactured with this defect. These units were distributed in the United States (Colorado, Indiana, New Jersey, and Texas) and internationally (Germany and Italy). The specific affected serial numbers are: 210125/2259, 210125/2262, 210125/2268, 210125/2260, 210125/2264, 210125/2270, 210125/2272, and 210125/2273. The UDI-DI for the product is 04026575251278.
Patients and healthcare providers should verify the serial number of any LinkSymphoKnee Tibial Component to determine whether it is affected by this recall.
The recalled product
- Product
- LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Hazard
- manufacturing-defect
- corrosion
- implant-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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.
Distribution
Distributed nationwide across the United States.
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