Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
Summary
The FDA issued a Class II for Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm. by Wright Medical Technology Inc. Reason: The incorrect product is contained in the packaging..
Details
Source
Device Recall
External ID
Z-0393-2022
Action Date
2021-12-29
Status
Ongoing
Category
device
Product Description
Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
Lot/Code Info: Lot #1643355
Quantity Affected: 250 units
Reason for Recall
The incorrect product is contained in the packaging.
Distribution
Worldwide distribution in the states of AZ, IA, ID, NC, NY, VA, and WV. The countries of Canada, France, Germany, Lebanon, The Netherlands, Saudi Arabia, and United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-03
Company
Arlington, TN
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.
Wright Medical Technology Inc 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 (Wright Medical Technology Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Wright Medical Technology Inc have FDA actions?
Wright Medical Technology Inc 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-0393-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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