DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse sh

FDA device recall Z-1520-2013 · posted 2013-06-07 · Terminated

Recall details

Recalling firm

DePuy Orthopaedics, Inc.

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.

Action taken

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).

Root cause

Process control

Status

Terminated

Product code

HWT

Quantity affected

20 units

Distribution

Worldwide Distribution - USA Nationwide and countries of: Australia, Canada, Czech Republic, England, Germany, Switzerland and Turkey.

Date initiated

2013-05-03

Date posted

2013-06-07

Date terminated

2013-08-28

Location

Warsaw, IN