The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The pla
Summary
The FDA issued a Class II for The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) p by Wright Medical Technology, Inc.. Reason: Product was labelled with the incorrect manufacturing and distribution dates..
Details
Source
Device Recall
External ID
Z-0679-2022
Action Date
2022-03-09
Status
Terminated
Category
device
Product Description
The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The various plates model numbers differ from each other through among other things different curvatures, material strengths, lengths, number of plate holes and through different grades and bridge widths
Lot/Code Info: Model No. DCS2825126; Lot No. 11012187061566009
Quantity Affected: 12 units
Reason for Recall
Product was labelled with the incorrect manufacturing and distribution dates.
Distribution
International distribution in the countries of Japan and the United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-09
Company
Memphis, 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 130 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-0679-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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