FDAClass IIJanuary 19, 2022

Global Unite REV Stem SZ 8 recall

GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600

Why was Global Unite REV Stem SZ 8 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 9887449 GTIN:10603295004059

Product
GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
3 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.
Recall date
January 19, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls