LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for pr
Summary
The FDA issued a Class II for LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5 by Linkbio Corp.. Reason: Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instea.
Details
Source
Device Recall
External ID
Z-1674-2023
Action Date
2023-06-07
Status
Ongoing
Category
device
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
Lot/Code Info: UDI-DI : 04026575258123 Lot Number: 1910003
Quantity Affected: 11 units
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).
Distribution
US Nationwide Distribution - AL, GA, IL, IN, LA, NV, TX
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-25
Company
Rockaway, 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 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Linkbio Corp. has 51 FDA actions in our database, including 50 recalls and 1 clearance.
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 (Linkbio Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Linkbio Corp. have FDA actions?
Linkbio Corp. has 51 FDA actions in our database, including 50 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1674-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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