Recall Z-1674-2023— Linkbio Corp.
Class II · Ongoing
Class II FDA medical device recall by Linkbio Corp., initiated 2023-04-25. It names one FDA 510(k) clearance: K202924. 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. 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)..
- Recalling firm
- Linkbio Corp.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-04-25
- Firm location
- Rockaway, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.