FDA Device recall Z-0881-2020
2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to…
- FDA Device
- Class II
- terminated
- Published 2020-02-05
On 2020-02-05 the FDA classified a Class II recall of 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to… by Synthes, citing 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 scr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0881-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-16 |
| Published | 2020-02-05 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Synthes |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Lot Number: 6L20591, 6L37063 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0881-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.