Recall Z-1680-2016 ยท HWC Screw, Fixation, Bone
Zimmer Manufacturing B.V.
Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 75 mm Length 47115507507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 90 mm Length 47115509007
| 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 | 90 |
| 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
| K143165 | Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Zimmer, Inc., Mar 31, 2015 |