Reported Dec 17, 2025 · Ongoing

Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti…

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

Lot codes and dates: Lot CodeAll
Lot Codes/ UDI
188 of 188 codes
38-2006SP
18257200151769
38-2007SP
18257200151776
38-2008SP
18257200151783
38-2009SP
18257200151790
38-2010SP
18257200151806
38-2011SP
18257200151813
38-2012SP
18257200151820
38-2013SP
18257200151837
38-2014SP
18257200151844
38-2106SP
18257200151875
38-2107SP
18257200151882
38-2108SP
18257200151899
38-2109SP
18257200151905
38-2110SP
18257200151912
38-2111SP
18257200151929
38-2112SP
18257200151936
38-2113SP
18257200151943
38-2114SP
18257200151950
38-2206SP
18257200151981
38-2207SP
18257200151998
38-2208SP
18257200152001
38-2209SP
18257200152018
38-2210SP
18257200152025
38-2211SP
18257200152032
38-2212SP
18257200152049
38-2213SP
18257200152056
38-2214SP
18257200152063
38-2309SP
18257200152094
38-2310SP
18257200152100
38-2311SP
18257200152117
Amount recalled: 14201

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Labeling contains claims that are not consistently present.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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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