MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device
Summary
The FDA issued a Class II for MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device by Medacta Usa Inc. Reason: There is a potential for breakage of the small screw used to affix the anti-backout plate..
Details
Source
Device Recall
External ID
Z-1403-2023
Action Date
2023-04-26
Status
Completed
Category
device
Product Description
MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device
Lot/Code Info: UDI/DI 07630345732316, All Lot Numbers
Quantity Affected: 34 units
Reason for Recall
There is a potential for breakage of the small screw used to affix the anti-backout plate.
Distribution
US: ID, TX, GA, VA, AZ
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-08
Company
Memphis, TN
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.
Medacta Usa Inc has 8 FDA actions in our database, including 8 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 (Medacta Usa Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medacta Usa Inc have FDA actions?
Medacta Usa Inc has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1403-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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