Reported Oct 13, 2021 · Ongoing
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX).…
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 Logic
- RBK PS Tibial Components (Product Line02-012-38-XXXX)
- NOTEInformation reflects Exactech recall expansion initiated on 02/07/2022
- Lot codes and dates
- Item Number (Device Identifier
- Serial number(s))
3,574 of 3,574 codes
02-012-38-1009 (1088586200235821092422109243210924421092452109246210924721092482109249210925021092512109252210925321092542109255210925621092572109258210926121092622109263210926521092672109268210926921092702109271210927221092732109274232803223280332328034235632423563252356326235632723563282356329235633023563312356332235633423563352356336257319825731992573200257320125732022573203257320429741152974116297411729741182974119299180629918072991808
- Amount recalled
- 8,985 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.
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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