Recall Z-0881-2020 ยท HRS Plate, Fixation, Bone
Synthes, Inc.
2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
| Date | Dec 16, 2019 |
| Status | Terminated |
| Reason | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Correction notification letter dated 12/16/19 was distributed to customers. Instructions to follow: To reduce the possibility of the inner cap coming loose or the inner tube remaining in the outer tube while removing the outer cap follow these techniques: " Option 1: Suggested opening technique for all affected lots 1. When opening the outer tube, ensure that the inner cap and inner tube are intact and turning freely in the outer tube 2. If the inner cap is not turning freely, push the outer cap towards the tube and keep turning counter-clockwise until you see the i |
| Quantity | 25 total |
| Distribution | US Nationwide distribution in the states of AL and ID. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103243 | 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM Synthes (Usa), Jan 21, 2011 |