Reported May 5, 2021 · Terminated
InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct…
Nextremity Solutions
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: Nextremity Solutions · 6210 N Buffalo St · Warsaw, IN · 46580
Is this the product you have?
- InCore Lapidus Disposable Kit 28mm Left
- Part NumberIC-LAP-28L -
- Product UsageIntended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis
- Lot codes and dates
- Lot Number168B29619A
- UDI00817701020868
- Amount recalled
- 111 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
Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended
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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