Device product
GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
Z-0485-2022
Product summary
- Event
- Event 89240
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-0485-2022
Official wording
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/or bone damage
Code information: Lot #: 9887449 GTIN:10603295004059
Distribution pattern: 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.
Derived failure modes
-
Unknown
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