Reported Dec 17, 2025 · Ongoing
Brand Name
Orthofix U.S. LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Orthofix U.S. LLC · 3451 Plano Pkwy · Lewisville, TX · 75056-9453
Is this the product you have?
Brand Name
16 of 16 products
| Model / number | Product as published |
|---|---|
33W | 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 |
37W | 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 |
- Lot codes and dates
- Lot CodeAll
- Lot Codes/ UDI
39-9012SP1825720011263039-9014SP1825720011264739-9016SP1825720011265439-9018SP1825720011266139-9212SP1825720011267839-9214SP1825720011268539-9216SP1825720011269239-9218SP1825720011270839-2012SP1825720011271539-2014SP1825720011272239-2016SP1825720011273939-2018SP1825720011274639-2212SP1825720011275339-2214SP1825720011276039-2216SP1825720011277739-2218SP18257200112784
- Amount recalled
- 13317
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Labeling contains claims that are not consistently present.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Orthofix U.S. LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.