Reported Oct 13, 2021 · Ongoing
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech…
Exactech, Inc.
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: Exactech, Inc. · 2320 Nw 66th Ct · Gainesville, FL · 32653-1630
Is this the product you have?
- OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components
- NOTEInformation reflects Exactech recall expansion initiated on 02/07/2022
- Lot codes and dates
- Item Number (Device Identifier
- Serial number(s))
3,607 of 3,607 codes
264-21-09 (1088586206884207543870754388075439007543910754392075439307543940754396075439707543980754399075440007544010754402075440307544040754405075440607544070754408075440907544100754411075441207544130754414075441507544160754417075441807544190754420075442107544220754423075442407544250754426075442707823950782396078239707823980782399078240007824010782402078240307824040782405078240607824070782408078240907824100782411078241207824130782414
- Amount recalled
- 33,103 devices
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
Why it was recalled
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
This product could cause temporary or reversible health problems — stop using it.
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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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