Recall Z-0589-2014 ยท FZX Guide, Surgical, Instrument
Zimmer, Inc.
ITST THREADED GUIDE PIN
| Date | Dec 27, 2013 (initiated Nov 5, 2013) |
| Status | Terminated |
| Reason | Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure |
| Root cause | Process change control |
| Action | On 11/5/2013, Urgent Medical Device Recall Notifications were sent to affected distributors, hospital Risk Managers, and doctors informing them of the failure. All distributors were notified via electronic mail. Hospital risk managers, surgeons and distributors with affected inventory within the expiration date of the device will also be notified via courier. The letter identifies the issue, health risks, and their responsibilities. Questions concerning the recall are directed to 1-877-946-2761 Communications outside of the United States will occur approximately two weeks after the United St |
| Quantity | 42, 065 units total |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082078 | ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PROXIMAL ULNA PLATES Zimmer, Inc., Nov 3, 2008 |