CLASS III ONGOING Device recall · Reported 17 Dec 2025 · FDA Enforcement Report
Pillar" SA PTC Spacer System recalled by Orthofix U.S
Orthofix U.S is recalling Pillar" SA PTC Spacer System, distributed nationwide in the US. The recall was initiated on 3 Nov 2025 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0893-2026
- FDA event ID
- 97862
- Recalling firm
- Orthofix U.S, Lewisville, TX
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 3 Nov 2025
- FDA classified
- 11 Dec 2025
- Reported
- 17 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 3 Nov 2025 | Recall initiated by company | |
| 11 Dec 2025 | Classified by FDA | +38 days |
| 17 Dec 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling contains claims that are not consistently present.
Product as listed by the FDA
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;
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Why was it recalled?
Labeling contains claims that are not consistently present.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 97862This product is part of a recall event; the main page for the event is Forza" Ti Spacer System recalled by Orthofix U.S.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Forza" Ti Spacer System recalled by Orthofix U.S | Orthofix U.S | Other | Nationwide | |
| CLASS III | Construx" Mini Ti Spacer System recalled by Orthofix U.S | Orthofix U.S | Other | Nationwide | |
| CLASS III | Construx" Mini PTC Spacer System recalled by Orthofix U.S | Orthofix U.S | Other | Nationwide | |
| CLASS III | Firebird" SI Fusion System recalled by Orthofix U.S | Orthofix U.S | Other | Nationwide | |
| CLASS III | Forza" PTC Spacer System recalled by Orthofix U.S | Orthofix U.S | Other | Nationwide |
More recalls from Orthofix U.S
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Orthofix Minirail, Short, Lengthener recalled by Orthofix U.S | Orthofix U.S | Labeling Errors | 22 states |
| Device | CLASS II | Orthofix Minirail, Articulated, Fixator, Vertical Axis recalled | Orthofix U.S | Labeling Errors | 22 states |
| Device | CLASS II | Orthofix Articulated Minirail Fixator Horizontal Axis recalled | Orthofix U.S | Labeling Errors | 22 states |
| Device | CLASS II | Orthofix Minirail, Standard Lengthener recalled by Orthofix U.S | Orthofix U.S | Labeling Errors | 22 states |
| Device | CLASS III | Forza" PTC Spacer System recalled by Orthofix U.S | Orthofix U.S | Other | Nationwide |
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