EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
Summary
The FDA issued a Class II for EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Ortho by Encore Medical, LP. Reason: Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available .
Details
Source
Device Recall
External ID
Z-0125-2023
Action Date
2022-11-02
Status
Ongoing
Category
device
Product Description
EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
Lot/Code Info: UDI-DI/Lot: 00190446309833/629Z1085
Quantity Affected: 4
Reason for Recall
Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.
Distribution
US Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-12
Company
Austin, TX
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 128 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Encore Medical, LP has 44 FDA actions in our database, including 44 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 (Encore Medical, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Encore Medical, LP have FDA actions?
Encore Medical, LP has 44 FDA actions in our database, including 44 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0125-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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