Summary
The FDA issued a Class II for EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705 by Encore Medical, LP. Reason: 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices ma.
Details
Source
Device Recall
External ID
Z-1233-2026
Action Date
2026-02-11
Status
Ongoing
Category
device
Product Description
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Lot/Code Info: UDI-DI: 00888912167529. Lot: 139T1075A. Expiration: 03-12-2026
Quantity Affected: 19
Reason for Recall
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Distribution
US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-05
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 207 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-1233-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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