Reported Apr 4, 2018 · Terminated
1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, 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. AutoPlex System
- Product Number0605-887-000
- UDI
(01)45465405931082
- AutoPlex Systemw/ VertaPlex HV
- Product Number0607-687-000
- UDI(01)7613252039259 Bone cement
- Lot codes and dates
- 1
- Lot Number
172780122
- Lot Numbers
17278012172780221727902217282012172820221729101217291022
- UDI
(01)4546540593108(01)7613252039259
- Amount recalled
- 1244
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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