Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
Summary
The FDA issued a Class II for Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 1516 by DePuy Orthopaedics, Inc.. Reason: The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for expos.
Details
Source
Device Recall
External ID
Z-1267-2023
Action Date
2023-03-29
Status
Ongoing
Category
device
Product Description
Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
Lot/Code Info: GTIN: 10603295049944; Lot: JN6613
Quantity Affected: 12 units
Reason for Recall
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-15
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 128 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-1267-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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