Recall Z-0783-2014 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Zimmer, Inc.
Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to address significant bone loss resulting from oncology, trauma, and/or salvage of previously failed arthroplasty.
| Date | Jan 17, 2014 (initiated Dec 19, 2013) |
| Status | Terminated |
| Reason | After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert. |
| Root cause | Device Design |
| Action | Depth of recall " Notifications were sent to customers, surgeons and risk managers, which use the affected product. Distributors were also informed of the notifications sent to surgeons and risk managers. The customers were identified by performing an invoice search and distribution history for the Polyethylene Inserts (00-5850-012-95 and 00-5850-013-95) since product launch. Recall Communication " All distributors were notified via electronic mail. Distributors that have received affected inventory were also notified via courier. Hospital risk managers and surgeons were also notifie |
| Quantity | 5305 distribution events |
| Distribution | Worldwide Distribution. USA nationwide and Germany, with further distribution into EU countries. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070978 | ZIMMER SEGMENTAL SYSTEM Zimmer, Inc., Jul 3, 2007 |