Recall Z-1674-2023
Linkbio Corp. · initiated April 25, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: UDI-DI : 04026575258123 Lot Number: 1910003
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).
FDA-determined cause: Under Investigation by firm
Action taken
LinkBio Corp. issued Urgent Medical Device Recall on 4/25/23 via email to Distributors. Letter states reason for recall, health risk and action to take: Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return the affected product. Pre-paid shipping labels will be provided once the Distributor Reply Form is returned. Please return the product as soon as possible to the following address: LinkBio Corporation 69 King St Dover, NJ 07801. Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions.
Details
- Recall number
- Z-1674-2023
- Initiated
- April 25, 2023
- Posted by FDA
- June 1, 2023
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Quantity
- 11 units
- Distribution
- US Nationwide Distribution - AL, GA, IL, IN, LA, NV, TX
- Recalling firm
- Linkbio Corp., Rockaway, NJ