ACell Recalls Gentrix Surgical Matrix Thick Due to Tensile Strength Failure
ACell, Inc. is recalling one lot of Gentrix Surgical Matrix Thick devices because a sample failed to meet tensile strength specifications.
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, but the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
ACell, Inc. is recalling one lot of Gentrix Surgical Matrix Thick, 30 x 40cm (Catalog Number PSMT3040, Lot 013948). The device is intended for implantation to reinforce soft tissue in patients requiring gastroenterological or plastic and reconstructive surgery, including hernia and body wall repair.
The recall was initiated because one sample from the lot failed to meet the company's tensile strength specification for lot release. The affected devices were distributed nationwide in the state of California.
Consumers and healthcare providers should stop using the affected devices and contact ACell, Inc. for further instructions.
The recalled product
- Product
- Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive…
- Manufacturer
- ACell, Inc
- Category
- Medical Device — Surgical Mesh
- Hazard
- Affected units
- 1
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 (1)
- SN KN000087
Distribution
Part of a larger recall action
This product is one of 2 recalled by ACell, Inc 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.
See all 2 products in this recall →Related recalls
Same manufacturer · ACell, Inc
See all →- ModerateACell Recalls Gentrix Surgical Matrix Thick Due to Tensile Strength Failure
FDA (Devices) · 2019-03-27
Same hazard · structural failure
See all →- High
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