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.
The agency’s classification
FDA (Food): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Product tested positive Salmonella ."
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.
See all 52 products in this recall →Related recalls
Same manufacturer · CHETAK NEW YORK LLC
See all →- CriticalFrozen punjabi tinda recalled after the product tested positive for Salmonella
FDA (Food) · 2025-12-17
- SevereNebivolol tablets recalled over cross contamination with other products
FDA (Food) · 2025-12-17
- SevereQuick Strip fabric bandages, 1 by 3 inch, recalled over open seals
FDA (Food) · 2025-12-17
- CriticalFrozen green channa recalled after testing positive for Salmonella
FDA (Food) · 2025-12-17
- CriticalFrozen sliced carrots recalled after testing positive for Salmonella
FDA (Food) · 2025-12-17
Same hazard · labeling inconsistency
See all →- ModerateTitanium spacer implants recalled over labeling claims not consistently present
FDA (Devices) · 2025-12-17
- ModerateSacroiliac fusion screws recalled over labeling claims not consistently present
FDA (Devices) · 2025-12-17
- ModerateTitanium spinal spacers recalled over labeling claims not consistently present
FDA (Devices) · 2025-12-17
- ModeratePTC spacer implants recalled over labeling claims not consistently present
FDA (Devices) · 2025-12-17
- ModerateMini PTC spacer implants recalled over labeling claims not consistently present
FDA (Devices) · 2025-12-17
Similar recalls
- ModerateTitanium spacer implants recalled over labeling claims not consistently present
FDA (Devices) · 2025-12-17
- ModeratePTC spacer implants recalled over labeling claims not consistently present
FDA (Devices) · 2025-12-17
- ModerateMini PTC spacer implants recalled over labeling claims not consistently present
FDA (Devices) · 2025-12-17
- ModerateTitanium spinal spacers recalled over labeling claims not consistently present
FDA (Devices) · 2025-12-17
- ModerateSacroiliac fusion screws recalled over labeling claims not consistently present
FDA (Devices) · 2025-12-17
- ModerateOrthofix Pillar SA Ti Spacer System Mislabeled for Anterior Height
FDA (Devices) · 2025-04-02