Class III — Orthofix U.S. LLC
| Recalling firm | ORTHOFIX SRL |
|---|---|
| Registered facility | ORTHOFIX SRL (the firm's only registered facility) |
| Classification | Class III |
| Status | Ongoing |
| Reason | Labeling contains claims that are not consistently present. |
| Product | Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0®, 9W x 23L x 7H 38-1008SP FORZA PTC Spacer, Straight, 0®, 9W x 23L x 8H; 38-1009SP FORZA PTC Spacer, Straight, 0®, 9W x 23L x 9H; 38-1010SP FORZA PTC Spacer, Straight, 0®, 9W x 23L x 10H; 38-1011SP FORZA PTC Spacer, Straight, 0®, 9W x 23L x 11H; 38-1012SP FORZA PTC Spacer, Straight, 0®, 9W x 23L x 12H; 38-1013SP FORZA PTC Spacer, Straight, 0®, 9W x 23L x 13H; 38-1014SP FORZA PTC Spacer, Straight, 0®, 9W x 23L x 14H; 38-1707SP FORZA PTC Spacer, Curv… |
| Quantity | 34582 |
| 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. |
| Initiated | 2025-11-03 |
| Classified | 2025-12-11 |
| Recall number | Z-0892-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Orthofix U.S. LLC (Z-0892-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97862/
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