Link SymphoKnee Sizing Template (Link Bio) – Labeling Error (2024)
Incorrect medical device labeling can potentially cause measurement confusion.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
Brand
LINK BIO CORP
Lot Codes / Batch Numbers
Item Number: 881-509/00, UDI-DI: 04026575310203, Lot number: C225066.
Products Sold
Item Number: 881-509/00; UDI-DI: 04026575310203; Lot number: C225066.
LINK BIO CORP is recalling LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00 due to The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of the instrument were mixed up because the triangular Pa. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of the instrument were mixed up because the triangular Patella Sizing Template was inserted upside down into the laser marking process.
Recommended Action
Per FDA guidance
On June 27, 2024 URGENT: MEDICAL DEVICE RECALL letters were sent via email to distributors. Actions to be taken by the Customer/User: Please check your inventory for this item and lot combination. If the markings are incorrect, as indicated in Section 5 below, please return the affected product to LinkBio. Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return any affected product. Pre-paid shipping labels will be provided once the Distributor Reply Form is returned, should any affected product be identified. Please return any affected 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. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
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