Device product
2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
Z-0883-2020
Product summary
- Firm
- Synthes, Inc.
- Event
- Event 84593
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25 total
- Official record key
device-enforcement:Z-0883-2020
Official wording
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.
Code information: Lot Number: 6L37876
Distribution pattern: US Nationwide distribution in the states of AL and ID.
Derived failure modes
-
Unknown
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.