Reported Oct 13, 2021 · Ongoing
OPTETRAK Comprehensive Knee System custom devices 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 Comprehensive Knee System custom devices labeled as the following
3 of 3 products
| # | Product as published |
|---|---|
| 1 | CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX) |
| 2 | CUSTOM OPTETRAK CC TIBIAL INSERT (Product Line: 900-23-XX, 900-30-XX) |
| 3 | CUSTOM OPTETRAK CC INSERT (Product Line: 900-33-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022. |
- Lot codes and dates
3 of 3 products
Products covered by this recall # Barcodes Product as published 1 108858621003751088586210038210885862100399108858621004051088586210041210885862100429Item Number (Device Identifier; Serial number(s)): 900-06-18 (10885862100375; 1667962, 1667963); 900-06-20 (10885862100382; 1667796, 1667797); 900-06-22(10885862100399; 1667744, 1667745); 900-08-18 (10885862100405; 1667794, 1667795); 900-08-20 (10885862100412; 1667929, 1667930); 900-08-22 (10885862100429; 1667879, 1667880) 2 10885862100863108858621008701088586210088710885862100894108858621009001088586210106810885862101075Item Number (Device Identifier; Serial number(s)): 900-23-02 (10885862100863; 0899804, 0899805, 0899806, 0899807); 900-23-03 (10885862100870; 0900400, 0900401, 0900402, 0900403); 900-23-04 (10885862100887; 0900408, 0900409, 0900410, 0900411, 0900412); 900-23-05 (10885862100894; 0900413, 0900414, 0900415, 0900416); 900-23-06 (10885862100900; 0900404, 0900405, 0900406, 0900407); 900-30-11 (10885862101068; 0565754, 0565755); 900-30-13 (10885862101075; 0565756, 0565757) 3 1088586210108210885862101099Item Number (Device Identifier; Serial number(s)): 900-33-09 (10885862101082; 1822113, 1822114); 900-33-11 (10885862101099; 1822115, 1822116) - Amount recalled
- 41 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.
Free recall alerts
Get alerted about new packaged foods recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.