TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Summary
The FDA issued a Class II for TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of by Limacorporate S.p.A. Reason: Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis..
Details
Source
Device Recall
External ID
Z-1261-2023
Action Date
2023-03-22
Status
Ongoing
Category
device
Product Description
TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Lot/Code Info: Product Code: 1590.15.010 UDI-DI Code: 08033390128865 Lot Number: 2115522 Sterilization Lot Number: 2100241
Quantity Affected: 5 systems
Reason for Recall
Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
Distribution
U.S. Distribution to: TX
Type: Voluntary: Firm initiated
Recall Initiated: 2023-01-25
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 134 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-1261-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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