Linkbio Corp. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Linkbio Corp.
Lot Codes / Batch Numbers
UDI-DI : 04026575258123 Lot Number: 1910003
Products Sold
UDI-DI : 04026575258123 Lot Number: 1910003
Linkbio Corp. is recalling LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemente due to Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instea. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026