Recall Z-1437-2014 ยท HWT Template
DePuy Orthopaedics, Inc.
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 valid
| Date | Apr 9, 2014 (initiated Mar 28, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | 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. Ri |
| Quantity | 21,675 |
| Distribution | USA Nationwide Distribution including Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.