Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979
Summary
The FDA issued a Class II for Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTI by Stryker Spine. Reason: The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution..
Details
Source
Device Recall
External ID
Z-2101-2021
Action Date
2021-07-28
Status
Terminated
Category
device
Product Description
Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979
Lot/Code Info: lots A1903054, A1906006
Quantity Affected: 559 total
Reason for Recall
The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
Distribution
US Nationwide Distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-18
Company
Allendale, NJ
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 191 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker Spine has 13 FDA actions in our database, including 8 recalls and 5 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 Spine) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Spine have FDA actions?
Stryker Spine has 13 FDA actions in our database, including 8 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2101-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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