Knee tibial components recalled because security screws were left uncoated
LinkSymphoKnee modular TiNbN tibial components, size 5, REF 880-100/50, are recalled because some were manufactured with two uncoated security screws. 8 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; an implant component manufactured without its specified coating is a potential harm and no injuries are reported.
Plain-English summary
The LinkSymphoKnee System modular symmetric tibial component, size 5, CoCrMo/TiNbN, cemented and fixed, REF 880-100/50, UDI-DI 04026575251278, is being recalled. Affected serial numbers include 210125/2259, 210125/2262 and 210125/2268. The recall covers 8 units distributed in Colorado, Indiana, New Jersey and Texas, and in Germany and Italy.
The recall was issued because some modular LinkSymphoKnee TiNbN tibial components were manufactured with two uncoated security screws, which is incorrect. The FDA classified the action as Class II.
Hospitals and surgical centres holding these serial numbers should quarantine them and follow the manufacturer's instructions for return.
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)
- Affected units
- 8
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
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