Z-1520-2013Class II

DePuy Glenosphere orientation guide

Name: Z-1520-2013 DePuy Glenosphere orientation guide
Creator: DePuy Orthopaedics, Inc.
Published: 2013-05-03
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2013-05-03 / Terminated / root cause: manufacturing process

FDA source

DePuy Orthopaedics, Inc. began a recall of DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The orientation... on 2013-05-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1520-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-03
Posted: 2013-06-07
Terminated: 2013-08-28
Recalling firm: Depuy Orthopaedics Inc.
Product: 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.
Product code: HWT Template
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: DePuy Synthes sent and Urgent Information - Medical Device Instrument Recall Notice letter dated May 3, 2013 via email to affected customers. The letter identified the affected product, problem, clinical implications, and potential adverse events. Arrangements will be made for all affected Glenosphere Orientation Guides (part #230795000/lot #5120443) to be returned. Customers were asked to return the response form via fax (574-371-4964). Product related questions should be directed to DePuy Synthes Joint Reconstruction (1-888-554-2482). Recall inquiries should be directed to Kim Earle, Recall Coordinator, 574-371-4917 (M-F; 8a.m.-5 p.m. EDT).
Quantity in commerce: 20 units
Distribution: Worldwide Distribution - USA Nationwide and countries of: Australia, Canada, Czech Republic, England, Germany, Switzerland and Turkey.
Product codes and lots: Part Number 230795000/Lot Number 5120443

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1520-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1520-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-19	2013-06-07

Product code HWT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)