Recall Z-0872-06 ยท HWC Screw, Fixation, Bone
Pioneer Surgical Technology
Zimmer Cannulated Screw System Cannulated Driver, 5.0 mm Hex, REF 1147-49-50; Catalog # 00-1147-049-50. Manufactured by Pioneer Surgical Technology, Marquette, MI; Distributed by Zimmer, Warsaw, IN.
| Date | May 18, 2006 (initiated Mar 3, 2006) |
| Status | Terminated |
| Reason | There may be an obstruction in the cannula that will prevent the guide wire from passing through it. The obstruction in the cannula can force the guidewire to advance further into the patient than intended. |
| Root cause | Other |
| Action | Pioneer notified Zimmer via letter dated 3/3/06 and Zimmer notified their hospital customers and distribution sites via letters dated 3/10/06 to check their inventory and return the product immediately to Zimmer. |
| Quantity | 74 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003496 | CANNULATED SCREW SYSTEM Pioneer Surgical Technology, Feb 8, 2001 |