CLASS II Device recall · Reported 5 Feb 2020 · FDA Enforcement Report
Ti Va Locking Screw Stardrive Sterile recalled by Synthes
Synthes is recalling Ti Va Locking Screw Stardrive Sterile, distributed nationwide in the US. The recall was initiated on 16 Dec 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0881-2020
- FDA event ID
- 84593
- Recalling firm
- Synthes, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Dec 2019
- FDA classified
- 29 Jan 2020
- Reported
- 5 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 16 Dec 2019 | Recall initiated by company | |
| 29 Jan 2020 | Classified by FDA | +44 days |
| 5 Feb 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of AL and ID.
Questions about this recall
Why was it 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 lots are affected?
Lot Number: 6L20591, 6L37063
Where was it sold?
US Nationwide distribution in the states of AL and ID.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 84593This product is part of a recall event; the main page for the event is Ti Va Locking Screw Stardrive Sterile recalled by Synthes.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ti Va Locking Screw Stardrive Sterile recalled by Synthes | Synthes | Sterility | Nationwide | |
| CLASS II | Ti Va Locking Screw Stardrive Sterile recalled by Synthes | Synthes | Sterility | Nationwide | |
| CLASS II | Ti Va Locking Screw Stardrive Sterile recalled by Synthes | Synthes | Sterility | Nationwide | |
| CLASS II | Ti Va Locking Screw Stardrive Sterile recalled by Synthes | Synthes | Sterility | Nationwide |
More recalls from Synthes
All 43| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MatrixNEURO Screws recalled by Synthes | Synthes | Packaging Defects | PA |
| Device | CLASS II | Ti Va Locking Screw Stardrive Sterile recalled by Synthes | Synthes | Sterility | Nationwide |
| Device | CLASS II | Ti Va Locking Screw Stardrive Sterile recalled by Synthes | Synthes | Sterility | Nationwide |
| Device | CLASS II | Ti Va Locking Screw Stardrive Sterile recalled by Synthes | Synthes | Sterility | Nationwide |
| Device | CLASS II | Ti Va Locking Screw Stardrive Sterile recalled by Synthes | Synthes | Sterility | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |