Reported Mar 7, 2018 · Terminated
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are 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 are 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
- 23,053 units
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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