Reported Dec 17, 2025 · Ongoing
Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC…
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 NameFORZA"
- PTC Spacer System Product NameFORZA"
- PTC Spacer System Model/Catalog Number
248 of 248 codes
38-1007SP FORZA PTC SpacerStraight0¿9W x 23L x 7H 38-1008SP FORZA PTC SpacerStraight0¿9W x 23L x 8H38-1009SP FORZA PTC SpacerStraight0¿9W x 23L x 9H38-1010SP FORZA PTC SpacerStraight0¿9W x 23L x 10H38-1011SP FORZA PTC SpacerStraight0¿9W x 23L x 11H38-1012SP FORZA PTC SpacerStraight0¿9W x 23L x 12H38-1013SP FORZA PTC SpacerStraight0¿9W x 23L x 13H38-1014SP FORZA PTC SpacerStraight0¿9W x 23L x 14H38-1707SP FORZA PTC SpacerCurved0¿9W x 27L x 7H38-1708SP FORZA PTC SpacerCurved0¿9W x 27L x 8H38-1709SP FORZA PTC SpacerCurved0¿9W x 27L x 9H38-1710SP FORZA PTC SpacerCurved0¿9W x 27L x 10H38-1711SP FORZA PTC SpacerCurved0¿9W x 27L x 11H38-1712SP FORZA PTC SpacerCurved0¿9W x 27L x 12H38-1713SP FORZA PTC SpacerCurved0¿9W x 27L x 13H38-1714SP FORZA PTC Spacer
- Lot codes and dates
- Lot CodeAll
- Lot codes/ UDIPart Number GTIN
76 of 76 codes
38-1007SP1825720009157738-1008SP1825720009158438-1009SP1825720009159138-1010SP1825720011140438-1011SP1825720009161438-1012SP1825720009162138-1013SP1825720009163838-1014SP1825720009164538-1707SP1825720009218538-1708SP1825720009219238-1709SP1825720009220838-1710SP1825720009221538-1711SP1825720009222238-1712SP1825720009223938-1713SP1825720009224638-1714SP1825720009225338-1807SP1825720009202438-1808SP1825720009203138-1809SP1825720009204838-1810SP1825720009205538-1811SP1825720009206238-1812SP1825720009207938-1813SP1825720011130538-1814SP1825720009209338-3007SP1825720009188138-3008SP1825720009189838-3009SP1825720009190438-3010SP1825720009191138-3011SP1825720009192838-3012SP18257200091935
76 of 76 codes
38-4013SP1825720009178238-4014SP1825720009179938-4207SP1825720009210938-4208SP1825720009211638-4209SP1825720009212338-4210SP1825720009213038-4211SP1825720009214738-4212SP1825720009215438-4213SP1825720009216138-4214SP1825720009217838-4508SP1825720009226038-4509SP1825720009227738-4510SP1825720009228438-4511SP1825720009229138-4512SP1825720009230738-4513SP1825720009231438-4514SP1825720009232138-6007SP1825720009180538-6008SP1825720009181238-6009SP1825720009182938-6010SP1825720009183638-6011SP1825720009184338-6012SP1825720009185038-6013SP1825720009186738-6014SP1825720009187438-7008SP1825720009165238-7009SP1825720009166938-7010SP1825720009167638-7011SP1825720009168338-7012SP18257200091690
- Amount recalled
- 34582
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.
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