Device product
LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-325/13
Z-1674-2023
Product summary
- Firm
- Linkbio Corp.
- Event
- Event 92294
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11 units
- Official record key
device-enforcement:Z-1674-2023
Official wording
Reason: Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).
Code information: UDI-DI : 04026575258123 Lot Number: 1910003
Distribution pattern: US Nationwide Distribution - AL, GA, IL, IN, LA, NV, TX
Derived failure modes
-
Unknown
Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).