Z-1520-2013 Class II Terminated
FDA device recall Z-1520-2013 was initiated by DePuy Orthopaedics, Inc. on May 3, 2013 and is designated Class II. Reason for recall: The Glenosphere Orientation Guide Instrument Used with the Delta XTEND Reverse Shoulder is being recalled because an arrow that is etched on the instrument was incorrectly placed on the opposite side… The recall status is terminated (terminated Aug 28, 2013). Affected quantity: 20 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 19, 2013
- Initiation Date
- May 3, 2013
- Termination Date
- Aug 28, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units
Product Description
DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The orientation guide is used to properly align the glenosphere.
Reason for Recall
The Glenosphere Orientation Guide Instrument Used with the Delta XTEND Reverse Shoulder is being recalled because an arrow that is etched on the instrument was incorrectly placed on the opposite side of the instrument. Using the improperly etched arrow as a guide could potentially lead to incorrect orientation of the glenosphere implant.
Distribution Pattern
Worldwide Distribution - USA Nationwide and countries of: Australia, Canada, Czech Republic, England, Germany, Switzerland and Turkey.
Code Information
Part Number 230795000/Lot Number 5120443
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1520-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026