Recall Z-0555-2010 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Zimmer Inc.
Zimmer, Insall/Burstein II Modular Knee System, Tibial Wedge and 2 Screws, Size 59, 7 Deg. x 9.5 mm Height, Tivanium TI-6AL-4V Alloy, sterile; REF 5220-62-01.
| Date | Dec 22, 2009 (initiated Feb 26, 2009) |
| Status | Terminated |
| Reason | Smaller diameter screws than required were included in the package. |
| Root cause | Process control |
| Action | Zimmer notified consignees by recall letter dated 2/25/09 instructing them to cease use of the device and to return it. Zimmer distributors and international accounts were notified by email on 2/26/09. |
| Quantity | 13 |
| Distribution | USA (Connecticut, Indiana, Pennsylvania), Australia, Serbia, Spain, Switzerland and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K862632 | INSALL/BURSTEIN(TM)* II TIBIAL WEDGES Zimmer, Inc., Mar 25, 1987 |