Recall Z-1678-2016 ยท HSB Rod, Fixation, Intramedullary And Accessories
Zimmer Manufacturing B.V.
M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length 00225307042
| 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 | 219 |
| 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
| K142281 | ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM Zimmer, Inc., Oct 22, 2014 |