Reported Apr 13, 2016 · Terminated
Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile…
Synthes (USA) Products LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synthes (USA) Products LLC · 1301 Goshen Pkwy · West Chester, PA · 19380-5986
Is this the product you have?
- Titanium Low Profile Neuro Screw, Self Drilling, 3mm
- part numbers
400.833400.833E
- Product UsageThe Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin
- Lot codes and dates
- Titanium Low Profile Neuro Screw, Self-Drilling, 3mm, part number # 400.833
- Lot numbers
996035999623009967875
- Amount recalled
- 500 units distributed in USA, and 35 units distributed OUS
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the thread height of the screws is undersized.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Synthes (USA) Products LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.