TEI Biosciences Recalls PriMatrix Acellular Dermal Tissue Matrix Due to Labeling Errors
TEI Biosciences is recalling 4,081 units of PriMatrix acellular dermal tissue matrix because some Instructions for Use contained missing or duplicate pages.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: The recall is classified as FDA Class II and involves minor labeling errors (missing/duplicate pages in IFUs) without reported injuries or illnesses, fitting the 'Moderate' severity criteria for low-risk contamination or labeling issues.
Plain-English summary
TEI Biosciences is recalling 4,081 units of PriMatrix, an acellular dermal tissue matrix derived from fetal bovine dermis. The recall was initiated after it was discovered during final assembly that some Instructions for Use (IFUs) from Lot RM1608011 contained extra or missing pages. Specifically, 22 IFUs had duplicate pages and were missing specific sections, 3 IFUs were missing pages, and 2 other IFUs were missing various sections including critical information on indications, contraindications, and warnings.
The affected lots were manufactured between February 2017 and May 2017 and are distributed in the U.S. The missing pages include sections with instructions in languages other than English, as well as pages containing essential safety information such as device description, warnings, precautions, and potential complications. The recall number is Z-0383-2018.
Healthcare providers and patients should stop using the affected PriMatrix units and contact TEI Biosciences for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.
- Manufacturer
- TEI Biosciences
- Hazard
- Affected units
- 4,081
Distribution
Distribution scope not specified by the agency.
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