PTC spacer implants recalled over labeling claims not consistently present
Orthofix U.S. is recalling 13,317 Pillar SA PTC Spacer System units because the labeling contains claims that are not consistently present.
- Product
- Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog Number: 39-9012SP 33W X 28L X 12.5H, 7DEG PTC IMPLANT; 39-9014SP 33W X 28L X 14H, 7DEG PTC IMPLANT; 39-9016SP 33W X 28L X 16H, 7DEG PTC IMPLANT; 39-9018SP 33W X 28L X 18H, 7DEG
- Category
- Medical Device
- Distribution
- Distributed nationwide