Torosa Saline-Filled Testicular Prosthesis (Size Small)
Summary
The FDA issued a Class II for Torosa Saline-Filled Testicular Prosthesis (Size Small) by Coloplast Manufacturing US, LLC. Reason: Product is mislabeled for size..
Details
Source
Device Recall
External ID
Z-0413-2022
Action Date
2021-12-29
Status
Terminated
Category
device
Product Description
Torosa Saline-Filled Testicular Prosthesis (Size Small)
Lot/Code Info: SKU# 5206102400; Catalo # (450-1325); Lot 7685283
Quantity Affected: 19 units
Reason for Recall
Product is mislabeled for size.
Distribution
Worldwide distribution - US Nationwide distribution and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-09
Company
Minneapolis, MN
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 113 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Coloplast Manufacturing US, LLC has 21 FDA actions in our database, including 21 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 (Coloplast Manufacturing US, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Coloplast Manufacturing US, LLC have FDA actions?
Coloplast Manufacturing US, LLC has 21 FDA actions in our database, including 21 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0413-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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