PTC spinal spacers recalled over labeling claims not consistently present
Orthofix U.S. is recalling 34,582 FORZA PTC Spacer System units because the labeling contains claims that are not consistently present.
What this means for you
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 PTC Spacer System from Orthofix U.S. LLC is being recalled, across a range of catalog numbers and sizes listed in the enforcement record, including 38-1007SP, 38-1008SP and 38-1009SP straight spacers at 9mm width by 23mm length with heights from 7mm to 9mm.
The reason given in the enforcement record is that the labeling contains claims that are not consistently present.
The record lists 34,582 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
- Deep-brand Premium Select Surti Undhiu Mix Net Wt. 12 oz. (340 g) KEEP FROZEN
- Manufacturer
- CHETAK NEW YORK LLC
- Category
- Medical Device — Spinal implant
- Affected units
- 3,509,532
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- Lot IN 25158K
- 24358
- 25024
- 25036
- 25052
- 25070
- 25092
- 25098
- 25125
- 25134
- 25158
- 25188
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 52 recalled by CHETAK NEW YORK LLC under a single FDA (Food) 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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