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.
Recall
- Recall Number
- Z-1437-2014
- Event Number
- 67691
- Firm
- DePuy Orthopaedics, Inc.
- FEI Number
- 1818910
- Product Code
- HWT
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- March 28, 2014
- Posted
- April 9, 2014
- Terminated
- December 4, 2014
- Address
- 700 Orthopaedic Dr, Warsaw, IN, 46582-3994
Description
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.
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.
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)
USA Nationwide Distribution including Canada
21,675