Collagen Matrix Recalls Porcine Anorganic Bone Mineral Due to Volume Mislabeled
Collagen Matrix Inc is recalling 136 units of Porcine Anorganic Bone Mineral 4.0cc because the product may contain only 2.0cc volume, resulting in mislabeling.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a labeling error regarding volume.
Plain-English summary
Collagen Matrix Inc is recalling 136 units of Porcine Anorganic Bone Mineral 4.0cc. The recall is due to a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume, which constitutes mislabeling.
The affected product is identified by UDI (01)00813954022369(17)210430(10)PMCU18C4, Lot Number PMCU18C4, and Expiration Date 04/30/2021. The recall number is Z-0752-2019.
The product was distributed in Florida and Texas. Consumers and healthcare providers should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- Porcine Anorganic Bone Mineral 4.0cc
- Manufacturer
- Collagen Matrix Inc
- Hazard
- Affected units
- 136
Distribution
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