ClearanceBrief
Recall Z-1520-2013 ยท HWT Template

DePuy Orthopaedics, Inc.

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.

DateJun 7, 2013 (initiated May 3, 2013)
StatusTerminated
ReasonThe 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 causeProcess control
ActionDePuy 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, Re
Quantity20 units
DistributionWorldwide Distribution - USA Nationwide and countries of: Australia, Canada, Czech Republic, England, Germany, Switzerland and Turkey.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.