Exactech Equinoxe Reverse Shoulder Implants Recalled for Nonconforming Packaging
Exactech is recalling 826 Equinoxe Reverse Shoulder humeral liners (Item Numbers 320-36-10 and 320-36-13) due to nonconforming packaging. The vacuum bags lack the required oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
- Product
- Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty
- Category
- Medical Device
- Distribution
- Distributed nationwide