Reported Apr 4, 2018 · Terminated
1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product…
Stryker Instruments Div. of Stryker Corporation
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: Stryker Instruments Div. of Stryker Corporation · 4100 E Milham Ave · Portage, MI · 49002-9704
Is this the product you have?
- 1. 11g/10mm iVAS System Kit
- Product Number0705-310-000
- UDI
(01)76132525059832. 11g/15mm iVAS System Kit
- Product Number0705-315-000
- UDI(01)7613252505969 for spinal orthopedic use
- Lot codes and dates
- 1
- Shelf Life12 months
- Lot Number
172770122
- Shelf Life36 months
- Lot Numbers
1728301217299012
- UDI
(01)7613252505983(01)7613252505969
- Amount recalled
- 504
This recall covers 14 products
The agency filed one notice per product. You are reading one of them; the other 13 are below.
1 more are in the archive.
Where it was sold
Why it was recalled
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
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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