Summary
The FDA issued a Class II for General Manual surgical instrument by M.D.L. S.r.l.. Reason: Sterility assurance may be compromised..
Details
Source
Device Recall
External ID
Z-2493-2021
Action Date
2021-09-29
Status
Terminated
Category
device
Product Description
General Manual surgical instrument
Lot/Code Info: Model MGC1413, Lot Numbers: 0817A Model MGC1825, Lot Numbers: 0817A Model MGP1410, Lot Numbers: 5216C Model MGP1412, Lot Numbers: 5216C Model MGP1612, Lot Numbers: 5216C Model MGP1820, Lot Numbers: 5216C Model MGP1825, Lot Numbers: 0817A Model PC1610, Lot Numbers: 3620D Model PC1810, Lot Numbers: 3620D Model PC1815, Lot Numbers: 1217B Model PM14075, Lot Numbers: 5216C Model PM1410, Lot Numbers: 3620D Model PM14114, Lot Numbers: 5216C Model PM1415, Lot Numbers: 5216C Model PM16075, Lot Numbers: 5216C Model PM1610, Lot Numbers: 3620D Model PM16114, Lot Numbers: 5216C Model PM1615, Lot Numbers: 5216C Model PM18075, Lot Numbers: 5216C Model PM18114, Lot Numbers: 5216C Model PM1815, Lot Numbers: 5216C Model VE1410, Lot Numbers: 3620D Model VES1825, Lot Numbers: 1417A
Quantity Affected: 4120 units
Reason for Recall
Sterility assurance may be compromised.
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-05
Company
Delebio
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 173 device recalls issued in the same week, part of 403 device-related FDA actions this month.
M.D.L. S.r.l. has 5 FDA actions in our database, including 5 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 (M.D.L. S.r.l.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does M.D.L. S.r.l. have FDA actions?
M.D.L. S.r.l. has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2493-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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