Titanium spacer implants recalled over labeling claims not consistently present
Orthofix U.S. is recalling 14,201 Forza Ti Spacer System units because the labeling contains claims that are not consistently present.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 under the rule that FDA Class III actions fall at 1 or 2: the record cites inconsistent labeling claims with no stated product defect or consequence.
Plain-English summary
The Forza Ti Spacer System from Orthofix U.S. LLC is being recalled, across a range of catalog numbers listed in the enforcement record including 38-2006SP, 38-2007SP and 38-2008SP straight spacers at 9mm width by 23mm length with heights of 6mm, 7mm and 8mm.
The reason given in the enforcement record is that the labeling contains claims that are not consistently present.
The record lists 14,201 units across all lot codes. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class III, its least serious category.
The record describes an inconsistency in labeling claims rather than a product defect, and states no injuries. Facilities should follow Orthofix's instructions.
The recalled product
- 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…
- Manufacturer
- Orthofix U.S. LLC
- Category
- Medical Device — Spinal implant
- Affected units
- 14,201
Distribution
Part of a larger recall action
This product is one of 6 recalled by Orthofix U.S. LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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