Reported Aug 17, 2016 · Terminated
Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation…
Integra LifeSciences Corp.
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: Integra LifeSciences Corp. · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344
Is this the product you have?
- Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixation Bolt - 23 mm Catalogue #12224219
- Lot codes and dates
- Lot # GT0420 and GT0419
- Amount recalled
- 495 units
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
Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site.
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.
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