Summary
The FDA issued a Class II for Everest MI XT Inner Dilator, Catalog Number 5101-90167 by K2M, Inc. Reason: Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedur.
Details
Source
Device Recall
External ID
Z-0705-2022
Action Date
2022-03-09
Status
Ongoing
Category
device
Product Description
Everest MI XT Inner Dilator, Catalog Number 5101-90167
Lot/Code Info: GTIN: 10888857261204; Lot Numbers: JUJF KFMV KUPG KYYU MDRB NDMK NDMX NXJK
Quantity Affected: 686 Total Devices
Reason for Recall
Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.
Distribution
Worldwide distribution - US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-13
Company
Leesburg, VA
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 130 device recalls issued in the same week, part of 403 device-related FDA actions this month.
K2M, Inc has 8 FDA actions in our database, including 4 recalls and 4 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 (K2M, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does K2M, Inc have FDA actions?
K2M, Inc has 8 FDA actions in our database, including 4 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0705-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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