PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
FDA device recall Z-2555-2025 · posted 2025-09-11 · Open, Classified
Recall details
- Recalling firm
- Orthofix U.S. LLC
- Reason for recall
- 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.
- Action taken
- On 6/24/2025, recall notes were emailed to customers who were asked to do the following: 1) Examine your inventory and quarantine any affected product. 2) If implanted, healthcare Providers should determine whether it is necessary to inform the patient, based on clinical judgment and individual circumstances. 3) This notice should be shared with all relevant personnel within your organization and forwarded to any other organization or facility where potentially affected devices may have been transferred. 4) Complete and return the response form to the firm. Should you have any questions regarding this matter, please contact the firm at madison.ebel@seaspine.com
- Root cause
- Labeling design
- Status
- Open, Classified
- Product code
- MAX
- Quantity affected
- 3
- Distribution
- US Nationwide distribution in the states of CO, CA.
- Date initiated
- 2025-06-24
- Date posted
- 2025-09-11
- Location
- Lewisville, TX
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PILLAR SA Ti Spacer System (82-XXX) (K240749) | Orthofix, Inc. | 2024-05-28 |