Z-0879-2020 Class II Terminated
FDA device recall Z-0879-2020 was initiated by Synthes, Inc. on December 16, 2019 and is designated Class II. Reason for recall: 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 remove… The recall status is terminated (terminated June 8, 2020). Affected quantity: 25 total.
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2020
- Initiation Date
- December 16, 2019
- Termination Date
- June 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 total
Product Description
2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of AL and ID.
Code Information
Lot Number: 6L37877