Recall Z-0561-04 ยท HWC Screw, Fixation, Bone
Pioneer Surgical Technology
Stayfuse brand intramedullary bone screw; MID 3.8 x 6 mm. Zimmer part number 00-2227-003-001.
| Date | Feb 27, 2004 (initiated Jan 20, 2004) |
| Status | Terminated |
| Reason | Product labeled as size 3.8x6 mm implant may actually be size 4.3x6 mm implant. |
| Root cause | Other |
| Action | Zimmer was notified of this recall via letter dated 1/20/04 requesting Zimmer to remove all of this lot from inventory and from point of use locations. |
| Quantity | 318 |
| Distribution | By Zimmer: Nationwide, Australia, Canada, Germany and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990804 | STAYFUSE Pioneer Surgical Technology, Apr 29, 1999 |