GLOBAL Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019, Non-Sterile, DePuy, Johnson & Johnso

FDA device recall Z-1437-2014 · posted 2014-04-09 · Terminated

Recall details

Recalling firm

DePuy Orthopaedics, Inc.

Reason for recall

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.

Action taken

Beginning 3/28/12014 DePuy United States Distributors and DePuy affiliate contacts for Canada and International will be notified via email. The US Distributors will be responsible for adhering to the directions outlined in the field communication, including identifying the Surgeon users and notifying them either by mail or in person with the Surgeon Letter and providing access to revised surgical techniques. The notice emphasized technical points regarding the use of the GLOBAL APG+ 2.5mm Breakaway Guide Pin (singleuse shoulder instrument) that have been added to the surgical techniques. Risks were explained and surgical techniques revised were identified and available through the distributor. Distributors were asked to identify surgeons using the device, filling out the response form. For clinical questions from surgeons, please contact DePuy Orthopaedics, Inc.s Scientific Information Office at 18885542482 (MF; 8 a.m. 5 p.m. EDT). For product related questions, please contact your local DePuy Orthopaedics, Inc., Sales Consultant." For questions about recall information provided: Kim Earle, Recall Coordinator, 5743714917 (MF; 8 a.m. 5 p.m. EDT)

Root cause

Device Design

Status

Terminated

Product code

HWT

Quantity affected

21,675

Distribution

USA Nationwide Distribution including Canada

Date initiated

2014-03-28

Date posted

2014-04-09

Date terminated

2014-12-04

Location

Warsaw, IN