ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the f
Summary
The FDA issued a Class II for ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation o by DePuy Orthopaedics, Inc.. Reason: Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode i.
Details
Source
Device Recall
External ID
Z-1419-2022
Action Date
2022-07-27
Status
Ongoing
Category
device
Product Description
ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525
Lot/Code Info: GTIN: 10603295434061 Lots: AB4536235, AB4733296, AB4841493, AB4810808, AB4841495, AB4904565, AB4967214, AB5004557, and AB5034303
Quantity Affected: 872 units
Reason for Recall
Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain
Distribution
Nationwide Foreign: Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lithuania, Mauritius, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Vietnam
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-29
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 176 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-1419-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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