Recall Z-1351-06 ยท HWC Screw, Fixation, Bone
Zimmer Inc.
Zimmer Herbert Cannulated Bone Screw System Bone Screw, 4.5 mm dia., 50 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 47-1155-50-05 (47115505005).
| Date | Aug 3, 2006 (initiated Jun 26, 2006) |
| Status | Terminated |
| Reason | Lack of assurance of sterility, as the sterile barrier packaging may have been compromised. |
| Root cause | Other |
| Action | Hospital accounts were notified via recall letter dated 6/26/06 and distributor accounts were notified via recall letter dated 6/28/06 to return the product. Recall was extended to additional lots via recall letter dated 7/26/06. |
| Quantity | 310 total for all catalog numbers |
| Distribution | Worldwide, including USA, Argentina, Brazil, Canada, China, England, France, Germany, Guatemala, Israel, Japan, Jordan, Lebanon, Poland, Saudi Arabia, Singapore, Spain, Taiwan, UAE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K792022 | HERBERT BONE SCREW Zimmer, Inc., Oct 26, 1979 |