Reported Oct 13, 2021 · Ongoing
OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following
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 LOGIC Polyethylene Tibial Inserts, labeled as the following
7 of 7 products
| # | Product as published |
|---|---|
| 1 | OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX |
| 2 | OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX |
| 3 | OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX |
| 4 | OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX |
| 5 | OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX |
| 6 | OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX |
| 7 | OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022. |
- Lot codes and dates
- a. Item Number (Device Identifier
- Serial number(s))
3,587 of 3,587 codes
02-012-35-0009 (108858620016411678465167847116784741678481195775320060362006037201381220433082092688255489825730584705904)02-012-35-0011 (10885862001658167830216783091678312196308920198012104502210450423632272666629380953138095374760880)02-012-35-0013 (1088586200166516784461678450209258120925842523130)02-012-35-0015 (108858620016721677680)02-012-35-1009 (10885862001689139342713934281393429139343013934311393432139343313934351393436139343713934381393439139344013934411398561139856213985631398564139856813985691398573139857513985781398579
- Amount recalled
- 109,787 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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