Recall Z-1342-06 ยท NDJ Screw, Fixation, Bone, Non-Spinal, Metallic
Zimmer Inc.
Zimmer M/DN Intramedullary Fixation 5.5 dia. cortical screw, 3.5 mm hex head, 95 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-95-55 (00225309555).
| 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
This recall record lists no 510(k) number.