Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the OR
Summary
The FDA issued a Class II for Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 520112 by Wright Medical Technology, Inc.. Reason: An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw..
Details
Source
Device Recall
External ID
Z-0786-2022
Action Date
2022-03-23
Status
Terminated
Category
device
Product Description
Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System.
Lot/Code Info: Lot #73967511638696
Quantity Affected: 1 package
Reason for Recall
An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw.
Distribution
International distribution to the country of France.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-15
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 145 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-0786-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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