—#117855

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.

FDA product code: HWT — Template
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Part Number 230795000/Lot Number 5120443

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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).

Recalling firm

Firm: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

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

Timeline

Recall initiated: 2013-05-03
Posted by FDA: 2013-06-07
Terminated: 2013-08-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #117855. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.