Exactech, Inc.JDIClass II

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

Exactech, Inc.'s record for this product code

MDR events2,277All time

Recalls3All time

510(k) clearances12All time

Recent MDR events

2,277 adverse event reports on file

Recalls

3 recall events for this product code

TerminatedUnknown
Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
View FDA record ↗
Open, ClassifiedUnknown
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
View FDA record ↗
Open, ClassifiedUnknown
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
View FDA record ↗

510(k) clearances

12 clearances for this product code