Recall Z-1679-2016 ยท HWC Screw, Fixation, Bone
Zimmer Manufacturing B.V.
Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 20 mm Length 00114205020 Mini Magna-Fx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 36 mm Length 00114205036 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 24 mm Length 00114205
| 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 | 751 |
| 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
| K142442 | MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM Zimmer, Inc., Oct 3, 2014 |