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.
Reported: February 5, 2020 Initiated: December 16, 2019 #Z-0881-2020
Product Description
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.
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.
Details
- Recalling Firm
- Synthes, Inc.
- Units Affected
- 25 total
- Distribution
- US Nationwide distribution in the states of AL and ID.
- Location
- West Chester, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Synthes, Inc.. Units affected: 25 total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 5, 2020. Severity: Moderate. Recall number: Z-0881-2020.
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