Reported Mar 7, 2018 · Terminated
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total…
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?
- DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.
- Lot codes and dates
440 of 440 codes
524848752484885248489524849052484915248497524849852484995248500524850152504205250421525042252504235250424525113652511375251138525113952511405261339526134052613415261342526134352620775262078526207952620805262081526309052630915263203526320452632055263206526379852637995264519526452052654945265495526549652654975265498526549952660885266089526609052665925266593526809052680915268092526809352684745269235526974152697425269743
- Amount recalled
- Quantities co-mingled under initial product
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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