ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
Summary
The FDA issued a Class II for ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement by DePuy Orthopaedics, Inc.. Reason: Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery.
Details
Source
Device Recall
External ID
Z-0074-2022
Action Date
2021-10-13
Status
Terminated
Category
device
Product Description
ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
Lot/Code Info: Lot Number: J6304Z GTIN: 10603295057642
Quantity Affected: 10 units
Reason for Recall
Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery
Distribution
US Nationwide distribution in the states of CA, LA, MN, MO, NC, NE, OR, PA, WA, WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-09
Company
Warsaw, IN
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 192 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DePuy Orthopaedics, Inc. has 31 FDA actions in our database, including 28 recalls and 3 clearances.
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 (DePuy Orthopaedics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DePuy Orthopaedics, Inc. have FDA actions?
DePuy Orthopaedics, Inc. has 31 FDA actions in our database, including 28 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0074-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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