| | Class 3 Device Recall Pillar" SA PTC Spacer System |  |
| Date Initiated by Firm | November 03, 2025 |
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| Date Posted | December 11, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0893-2026 |
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| Recall Event ID |
97862 |
| 510(K)Number | K172437 |
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| Product Classification |
Intervertebral fusion device with integrated fixation, lumbar - Product Code OVD
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| 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; |
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| Code Information |
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
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Recalling Firm/
Manufacturer |
Orthofix U.S. LLC
3451 Plano Pkwy
Lewisville TX 75056-9453
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| For Additional Information Contact | Orthofix Field Actions
214-937-2000 |
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Manufacturer Reason
for Recall | Labeling contains claims that are not consistently present. |
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FDA Determined
Cause 2 | Device Design |
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| Action | On November 3, 2025 Orthofix issued a recall notification via Email to affected consignees. In addition to informing consignees about the recall , Orthofix ask consignees to take the following actions:
1. Orthofix is removing claims regarding Nanovate Technology in materials, including but not limited to Operative Techniques, Product Brochures, Medical Education Documents, and the Orthofix website.
2. No product return is being requested. You may continue to use the product.
3. Distribute this Notice to all relevant personnel within your organization.
4. Forward this Notice to other organization or facilities where affected products may have been transferred.
5. Acknowledge this Notice and return the completed receipt form to fieldactions@orthofix.com
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| Quantity in Commerce | 13317 |
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| Distribution | Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and the countries of AU, DE, PR, GB, HU, CZ, CA, CL, AE, ZA, BR.
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = OVD
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