Reported Oct 13, 2021 · Ongoing
ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). 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?
- ARTHROFOCUS Polyethylene
- Tibial Inserts (Product Line
256-12-XX256-13-XX)
- NOTEInformation reflects Exactech recall expansion initiated on 02/07/2022
- Lot codes and dates
- Item Number (Device Identifier
- Serial number(s))
256-12-02 (No Device Identifier1208624120862512086261208627)256-12-03 (1088586206663312087741446326)256-13-02 (No Device Identifier12087101208715)256-13-03 (No Device Identifier12088591208863)256-13-04 (No Device Identifier12090101209013)
- Amount recalled
- 12 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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