Summary
The FDA issued a Class II for LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00 by LINK BIO CORP. Reason: The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of the instrument were mixed up because the triangular Pa.
Details
Source
Device Recall
External ID
Z-2445-2024
Action Date
2024-07-31
Status
Ongoing
Category
device
Product Description
LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
Lot/Code Info: Item Number: 881-509/00; UDI-DI: 04026575310203; Lot number: C225066.
Quantity Affected: 8 units
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of FL, GA, KS, OH, WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-27
Company
Dover, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (LINK BIO CORP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does LINK BIO CORP have FDA actions?
This is the only FDA action we have on record for LINK BIO CORP in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2445-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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