GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
Reported: January 19, 2022 Initiated: December 7, 2021 #Z-0488-2022
Product Description
GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
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
Details
- Recalling Firm
- DePuy Orthopaedics, Inc.
- Units Affected
- 870 units
- 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.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100. Recalled by DePuy Orthopaedics, Inc.. Units affected: 870 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 19, 2022. Severity: Moderate. Recall number: Z-0488-2022.
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