Summary
The FDA issued a Class II for PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610 by Limacorporate S.p.A. Reason: Due to incorrect product labeling.
Details
Source
Device Recall
External ID
Z-0524-2024
Action Date
2023-12-20
Status
Ongoing
Category
device
Product Description
PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Lot/Code Info: Product Code: 6539.54.610 UDI-DI Code: 08033390212786 Lot/Sterilization Numbers: 2122621 / 2200149 2203871 / 2200167
Quantity Affected: 33 devices
Reason for Recall
Due to incorrect product labeling
Distribution
U.S Distribution: AZ, CA, IL, LA, and NY
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-27
Company
San Daniele Del Friuli, N/A
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 238 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Limacorporate S.p.A has 11 FDA actions in our database, including 11 recalls.
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 (Limacorporate S.p.A) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Limacorporate S.p.A have FDA actions?
Limacorporate S.p.A has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0524-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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