FDA Device recall Z-2555-2025
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
- FDA Device
- Class II
- ongoing
- Published 2025-09-17
On 2025-09-17 the FDA classified a Class II recall of PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP by Orthofix U S, citing A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap info….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2555-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-24 |
| Published | 2025-09-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Orthofix U S |
| Distribution | US |
Product
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Reason
A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct.
Identifiers
| code_info | UDI-DI: 18257200161010, Lots: 001, 002, and 003 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Orthofix U S
- Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
FDA Device · Class II · 2026-07-22 · Orthofix U S - Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
FDA Device · Class II · 2026-07-22 · Orthofix U S - Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device
FDA Device · Class II · 2026-07-22 · Orthofix U S - Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
FDA Device · Class II · 2026-07-22 · Orthofix U S - Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0¿,…
FDA Device · Class III · 2025-12-17 · Orthofix U S
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2555-2025%22
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