Reported Oct 13, 2021 · Ongoing
OPTETRAK Comprehensive Knee System, 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, labeled as the following
10 of 10 products
| # | Product as published |
|---|---|
| 1 | OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX |
| 2 | OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX, 204-14-XX, 204-15-XX, 204-16-XX |
| 3 | OPTETRAK HI-FLEX PS Polyethylene Tibial Inserts, with Product Line Numbers: 244-20-XX, 244-21-XX, 244-22-XX, 244-23-XX, 244-24-XX, 244-25-XX |
| 4 | OPTETRAK CR Tibial Inserts, with Product Line Numbers: 200-21-XX, 200-22-XX, 200-23-XX, 200-24-XX, 200-25-XX, 200-26-XX, 200-50-XX, 200-51-XX |
| 5 | OPTETRAK CR Tibial Slope + Insert, with Product Line Numbers: 200-56-XX, 200-57-XX, 200-61-XX, 200-62-XX, 200-63-XX, 200-64-XX, 200-65-XX |
| 6 | OPTETRAK CR Tibial Slope ++ Insert, with Product Line Numbers: 200-57-XX, 200-71-XX, 200-72-XX, 200-73-XX, 200-74-XX, 200-75-XX |
| 7 | OPTETRAK PS Tibial Inserts, with Product Line Numbers: 204-21-XX, 204-22-XX 204-23-XX, 204-24-XX, 204-25-XX, 204-26-XX, 204-50-XX, 204-51-XX |
| 8 | OPTETRAK "MOMB" Non-Mod Molded Insert, with Product Line Numbers: 204-91-XX, 204-92-XX, 204-93-XX, 204-94-XX, 204-95-XX |
| 9 | OPTETRAK CC Tibial Insert, with Product Line Numbers: 208-21-XX, 208-22-XX, 208-23-XX, 208-24-XX, 208-25-XX, 208-51-XX |
| 10 | OPTETRAK B-Series PS Tibial Insert, with Product Line Numbers: 224-21-XX, 224-22-XX, 224-23-XX, 224-24-XX. Affected 510(k) numbers include: K932690, K933494, K932776, K011976, K082022, K933610, K030686, K954208, K010434, K033883. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022. |
- Lot codes and dates
- a. Item Number (Device Identifier
- Serial number(s))
295 of 295 codes
200-11-11 (108858620399341010599)200-12-09 (108858620399650850770085077108507730850776085077810525871052589107014910701501070151107015212675851267586126758813187391318740131874213758331375836137583713758391375844)200-12-11 (10885862039972082565108256530825654082565708256591052802105280310528041309224)200-12-13 (1088586203998907630410763043082042408204311053775)200-13-09 (10885862039996076538007653810765382076538307897230789724078972607897270789728078972907897300789731078973208976830998654099865509986560998657
- Serial number(s))
3,270 of 3,270 codes
204-11-09 (1088586204782309616630961665096166609616670961668096166909616710961672104587610458771045879107062010706221070623110679911068001106801110680211068031106805110680711934351193437119343811934391232147123215112559101255911125591212559131255914127080612708071270808127080913082201308221130822213082231308224130822513770161377017137701813770191377020137702113770221377023137702413770251545261154526215452631545264154526515657001565701
- Amount recalled
- 242,397 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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