Recall Z-1675-2016 ยท HWC Screw, Fixation, Bone
Zimmer Manufacturing B.V.
Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801
| Date | May 16, 2016 (initiated May 4, 2016) |
| Status | Terminated |
| Reason | A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. |
| Root cause | Packaging change control |
| Action | All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016. |
| Quantity | 200 |
| Distribution | Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082527 | ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS Zimmer, Inc., Dec 18, 2008 |