DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00
Summary
The FDA issued a Class II for DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 by Encore Medical, LP. Reason: Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packagi.
Details
Source
Device Recall
External ID
Z-2104-2021
Action Date
2021-07-28
Status
Ongoing
Category
device
Product Description
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
Lot/Code Info: Lot # 155T1035
Quantity Affected: 10 units
Reason for Recall
Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.
Distribution
US: Nationwide Distribution in the states of VA, MN, TX, IL, MS, CA, KS, LA, and GA OUS: None
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-12
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 191 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-2104-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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