Summary
The FDA issued a Class II for GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600 by DePuy Orthopaedics, Inc.. Reason: Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/.
Details
Source
Device Recall
External ID
Z-0485-2022
Action Date
2022-01-19
Status
Terminated
Category
device
Product Description
GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
Lot/Code Info: Lot #: 9887449 GTIN:10603295004059
Quantity Affected: 3 units
Reason for Recall
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Distribution
Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-07
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 106 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-0485-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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