Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S
Summary
The FDA issued a Class II for Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Cata by Stryker GmbH. Reason: The devices have a different inner diameter than the diameter specified on the outer box label..
Details
Source
Device Recall
External ID
Z-2170-2021
Action Date
2021-08-11
Status
Ongoing
Category
device
Product Description
Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S
Lot/Code Info: GTIN 07613327005417, Lot Number K03CC50
Quantity Affected: 52
Reason for Recall
The devices have a different inner diameter than the diameter specified on the outer box label.
Distribution
US Nationwide Distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-27
Company
Selzach
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.
Stryker GmbH has 27 FDA actions in our database, including 10 recalls and 17 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 (Stryker GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker GmbH have FDA actions?
Stryker GmbH has 27 FDA actions in our database, including 10 recalls and 17 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2170-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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