Gentrix Surgical Matrix Thick recall
Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for…
Why was Gentrix Surgical Matrix Thick recalled?
The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
SN KJ000423
- Product
- Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for…
- Recalling firm
- ACell, Inc
- Quantity
- 1
- Distribution
- US nationwide distribution in the state of CA.
- Recall date
- March 27, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)