FDA Device recall Z-0893-2026
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…
- FDA Device
- Class III
- ongoing
- Published 2025-12-17
On 2025-12-17 the FDA classified a Class III recall of 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… by Orthofix U S, citing labeling contains claims that are not consistently present.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0893-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-11-03 |
| Published | 2025-12-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Orthofix U S |
| Distribution | US |
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 PTC IMPLANT; 39-9212SP 33W X 28L X 12.5H, 12DEG PTC IMPLANT; 39-9214SP 33W X 28L X 14H, 12DEG PTC IMPLANT; 39-9216SP 33W X 28L X 16H, 12DEG PTC IMPLANT; 39-9218SP 33W X 28L X 18H, 12DEG PTC IMPLANT; 39-2012SP 37W X 28L X 12.5H, 7DEG PTC IMPLANT; 39-2014SP 37W X 28L X 14H, 7DEG PTC IMPLANT; 39-2016SP 37W X 28L X 16H, 7DEG PTC IMPLANT; 39-2018SP 37W X 28L X 18H, 7DEG PTC IMPLANT; 39-2212SP 37W X 28L X 12.5H, 12DEG PTC IMPLANT; 39-2214SP 37W X 28L X 14H, 12DEG PTC IMPLANT; 39-2216SP 37W X 28L X 16H, 12DEG PTC IMPLANT; 39-2218SP 37W X 28L X 18H, 12DEG PTC IMPLANT;
Reason
Labeling contains claims that are not consistently present.
Identifiers
| code_info | Lot Code: All Lot Codes/ UDI: 39-9012SP 18257200112630 39-9014SP 18257200112647 39-9016SP 18257200112654 39-9018SP 1825…Lot Code: All Lot Codes/ UDI: 39-9012SP 18257200112630 39-9014SP 18257200112647 39-9016SP 18257200112654 39-9018SP 18257200112661 39-9212SP 18257200112678 39-9214SP 18257200112685 39-9216SP 18257200112692 39-9218SP 18257200112708 39-2012SP 18257200112715 39-2014SP 18257200112722 39-2016SP 18257200112739 39-2018SP 18257200112746 39-2212SP 18257200112753 39-2214SP 18257200112760 39-2216SP 18257200112777 39-2218SP 18257200112784 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0893-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.