Class III U.S. Food and Drug Administration

Orthofix U.S. LLC Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer recall: Labeling contains claims that are not consistently present

Recall published 10 months ago

Labeling contains claims that are not consistently present.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Labeling contains claims that are not consistently present.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0895-2026
Published
December 17, 2025
Risk level
Class III
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Orthofix U.S. LLC
Product type
Medical devices
Units affected
14201
Distribution
Nationwide
Made in
United States
Lot / code info
Lot Code: All Lot Codes/ UDI: 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 38-2312SP 18257200152124 38-2313SP 18257200152131 38-2314SP 18257200152148 38-2508SP 18257200152360 38-2509SP 18257200152377 38-2510SP 18257200152384 38-2511SP 18257200152391 38-2512SP 18257200152407 38-2513SP 18257200152414 38-2514SP 18257200152421 38-3206SP 18257200152179 38-3207SP 18257200152186 38-3208SP 18257200152193 38-3209SP 18257200152209 38-3210SP 18257200152216 38-3211SP 18257200152223 38-3212SP 18257200152230 38-3213SP 18257200152247 38-3214SP 18257200152254 38-3409SP 18257200152285 38-3410SP 18257200152292 38-3411SP 18257200152308 38-3412SP 18257200152315 38-3413SP 18257200152322 38-3414SP 18257200152339 38-3506SP 18257200152759 38-3507SP 18257200152766 38-3508SP 18257200152773 38-3509SP 18257200152780 38-3510SP 18257200152797 38-3511SP 18257200152803 38-3512SP 18257200152810 38-3513SP 18257200152827 38-3514SP 18257200152834 38-3608SP 18257200152865 38-3609SP 18257200152872 38-3610SP 18257200152889 38-3611SP 18257200152896 38-3612SP 18257200152902 38-3613SP 18257200152919 38-3614SP 18257200152926 38-3706SP 18257200152957 38-3707SP 18257200152964 38-3708SP 18257200152971 38-3709SP 18257200152988 38-3710SP 18257200152995 38-3711SP 18257200153008 38-3712SP 18257200153015 38-3713SP 18257200153022 38-3714SP 18257200153039 38-3808SP 18257200153060 38-3809SP 18257200153077 38-3810SP 18257200153084 38-3811SP 18257200153091 38-3812SP 18257200153107 38-3813SP 18257200153114 38-3814SP 18257200153121 38-3908SP 18257200153152 38-3909SP 18257200153169 38-3910SP 18257200153176 38-3911SP 18257200153183 38-3912SP 18257200153190 38-3913SP 18257200153206 38-3914SP 18257200153213
UPC codes
18257200151769, 18257200151776, 18257200151783, 18257200151790, 18257200151806, 18257200151813, 18257200151820, 18257200151837, 18257200151844, 18257200151875, 18257200151882, 18257200151899, 18257200151905, 18257200151912, 18257200151929, 18257200151936, 18257200151943, 18257200151950, 18257200151981, 18257200151998

Products covered by this recall

Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 6H; 38-2007SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 7H; 38-2008SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 8H; 38-2009SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 9H; 38-2010SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 10H; 38-2011SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 11H; 38-2012SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 12H; 38-2013SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 13H; 38-2014SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 14H; 38-2106SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 6H; 38-2107SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 7H; 38-2108SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 8H; 38-2109SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 9H; 38-2110SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 10H; 38-2111SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 11H; 38-2112SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 12H; 38-2113SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 13H; 38-2114SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 14H; 38-2206SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 6H; 38-2207SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 7H; 38-2208SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 8H; 38-2209SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 9H; 38-2210SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 10H; 38-2211SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 11H; 38-2212SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 12H; 38-2213SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 13H; 38-2214SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 14H; 38-2309SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 9H; 38-2310SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 10H; 38-2311SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 11H; 38-2312SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 12H; 38-2313SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 13H; 38-2314SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 14H; 38-2508SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 8H; 38-2509SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 9H; 38-2510SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 10H; 38-2511SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 11H; 38-2512SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 12H; 38-2513SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 13H; 38-2514SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 14H; 38-3206SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 6H; 38-3207SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 7H; 38-3208SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 8H; 38-3209SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 9H; 38-3210SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 10H; 38-3211SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 11H; 38-3212SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 12H; 38-3213SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 13H; 38-3214SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 14H; 38-3409SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 9H; 38-3410SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 10H; 38-3411SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 11H; 38-3412SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 12H;

Check your product

The notice names 25 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 18257200151769
  • 18257200151776
  • 18257200151783
  • 18257200151790
  • 18257200151806
  • 18257200151813
  • 18257200151820
  • 18257200151837
  • 18257200151844
  • 18257200151875
  • 18257200151882
  • 18257200151899
  • 18257200151905
  • 18257200151912
  • 18257200151929
  • 18257200151936
  • 18257200151943
  • 18257200151950
  • 18257200151981
  • 18257200151998

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • UDI

Model or item number

On the rating label, the box or the instruction sheet.

  • 38-2006SP FORZA Ti Spacer

Package size

Match the net weight or the piece count on the front of the pack.

  • 23 L
  • 27 L
  • 31 L

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Orthofix U.S. LLC — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Orthofix U.S. LLC — 3451 Plano Pkwy, Lewisville, TX, 75056-9453

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Orthofix U.S. LLC medical devices recalled?

Labeling contains claims that are not consistently present. Labeling contains claims that are not consistently present.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 18257200151769, 18257200151776, 18257200151783; lot code UDI; model number 38-2006SP FORZA Ti Spacer. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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