I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
Summary
The FDA issued a Class II for I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175 by In2Bones, SAS. Reason: This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I..
Details
Source
Device Recall
External ID
Z-1319-2024
Action Date
2024-03-27
Status
Ongoing
Category
device
Product Description
I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
Lot/Code Info: UDI/DI 3760225710685, Batch Number 2306007, exp. 31/MAY/2028
Quantity Affected: 59 units
Reason for Recall
This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels.
Distribution
US Nationwide distribution in the state of Tennessee.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-26
Company
Ecully
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 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
In2Bones, SAS has 5 FDA actions in our database, including 2 recalls and 3 clearances.
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 (In2Bones, SAS) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does In2Bones, SAS have FDA actions?
In2Bones, SAS has 5 FDA actions in our database, including 2 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1319-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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