Recall Z-1437-2014— DePuy Orthopaedics, Inc.

Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2014-03-28, terminated 2014-12-04. FDA's recall record names no specific 510(k) clearance for this event. Product: GLOBAL¿ Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019, Non-Sterile, DePuy, Johnson & Johnson Product Usage: Usage: The GLOBAL APG+ 2.5mm Guide Pin is a single-use instrument that is used to assist the surgeon in the orientation of the cannulated reamer(s) and cannulated central drills in the preparation of the glenoid surface. The GLOBAL APG+ 2.5mm Guide Pin is validated for use with the GLOBAL APG+, GLOBAL STEPTECH APG, and DELTA XTEND Systems. The guide pin is scored in three locations, which allows the surgeon to select a desired pin length. The single-use shoulder instrument is made from 316L Stainless Steel.. Reason: Urgent Device Correction notifications are being sent to USA distributors with follow-up to surgeons concerning updated surgical techniques stressing the possibility of the shoulder pin guide breaking and potentially being left in the patient..

Recalling firm

DePuy Orthopaedics, Inc.

Classification

Class II

Status

Terminated

Initiated

2014-03-28

Terminated

2014-12-04

Firm location

Warsaw, IN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.