Recall Z-1676-2016 ยท HWC Screw, Fixation, Bone
Zimmer Manufacturing B.V.
Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, 16 mm length 47234702116
| 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 | 99 |
| 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
| K111447 | ZIMMER PERIARTICULAR SCREWS Zimmer, Inc., Oct 5, 2011 |