| | Class 3 Device Recall Forza" Ti Spacer System |  |
| Date Initiated by Firm | November 03, 2025 |
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| Date Posted | December 11, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0895-2026 |
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| Recall Event ID |
97862 |
| 510(K)Number | K203576 |
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| Product Classification |
Intervertebral fusion device with bone graft, lumbar - Product Code MAX
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| Product | 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; |
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| Code Information |
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
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Recalling Firm/
Manufacturer |
Orthofix U.S. LLC
3451 Plano Pkwy
Lewisville TX 75056-9453
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| For Additional Information Contact | Orthofix Field Actions
214-937-2000 |
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Manufacturer Reason
for Recall | Labeling contains claims that are not consistently present. |
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FDA Determined
Cause 2 | Device Design |
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| Action | On November 3, 2025 Orthofix issued a recall notification via Email to affected consignees. In addition to informing consignees about the recall , Orthofix ask consignees to take the following actions:
1. Orthofix is removing claims regarding Nanovate Technology in materials, including but not limited to Operative Techniques, Product Brochures, Medical Education Documents, and the Orthofix website.
2. No product return is being requested. You may continue to use the product.
3. Distribute this Notice to all relevant personnel within your organization.
4. Forward this Notice to other organization or facilities where affected products may have been transferred.
5. Acknowledge this Notice and return the completed receipt form to fieldactions@orthofix.com
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| Quantity in Commerce | 14201 |
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| Distribution | 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.
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = MAX
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