CLASS II ONGOING Device recall · Reported 5 Jun 2024 · FDA Enforcement Report
Stardrive Scrwdrvr Shft/T4/Self-retaining/Hxc-Intended recalled
Synthes (USA) Products is recalling Stardrive Scrwdrvr Shft/T4/Self-retaining/Hxc-Intended for tightening, loosening, or, distributed nationwide in the US. The recall was initiated on 25 Apr 2024 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-1916-2024
- FDA event ID
- 94546
- Recalling firm
- Synthes (USA) Products, West Chester, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Apr 2024
- FDA classified
- 28 May 2024
- Reported
- 5 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 25 Apr 2024 | Recall initiated by company | |
| 28 May 2024 | Classified by FDA | +33 days |
| 5 Jun 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in surgical delay
Product as listed by the FDA
STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Part Number: 03.130.010
Where it was distributed
Worldwide distribution - US Nationwide and the country of Canada.
Questions about this recall
Why was it recalled?
Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in surgical delay
Which lots are affected?
UDI-DI: 10886982075192 Lot Numbers: 97P6250, 97P6251, 97P6252
Where was it sold?
Worldwide distribution - US Nationwide and the country of Canada.
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.
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| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |