Reported Jan 19, 2022 · Terminated
GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
DePuy Orthopaedics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DePuy Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994
Is this the product you have?
- GLOBAL UNITE STD STEM SZ 8 Part Number110008100
- Lot codes and dates
Lot # s 9793035980213498021359802136980213798021389802139980214098021419802142980214398021449802145980214698021479802148980214998021509802151981451598171659817166981716798171689817633981833198243329824334982433598243369824337982433898243399824340982434198243429824343982434498243459824346982434798328049851705985170698517079851708986205798641479874672987467498746759874676987467898746829874683987468698746889887446
- GTIN10603295004042
- Amount recalled
- 432 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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