PTC spacer implants recalled over labeling claims not consistently present
Orthofix U.S. is recalling 13,317 Pillar SA PTC 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 Pillar SA PTC Spacer System from Orthofix U.S. LLC is being recalled, across a range of catalog numbers listed in the enforcement record including 39-9012SP, 39-9014SP and 39-9016SP, 33mm width by 28mm length PTC implants with heights of 12.5mm, 14mm and 16mm at 7 degrees.
The reason given in the enforcement record is that the labeling contains claims that are not consistently present.
The record lists 13,317 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: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog Number: 39-9012SP 33W X 28L X 12.5H, 7DEG PTC IMPLANT; 39-9014SP 33W X 28L X 14H, 7DEG PTC IMPLANT; 39-9016SP 33W X 28L X 16H, 7DEG PTC IMPLANT; 39-9018SP 33W X 28L X 18H, 7DEG…
- Manufacturer
- Orthofix U.S. LLC
- Category
- Medical Device — Spinal implant
- Affected units
- 13,317
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.
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