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ACell

2 recalls •
🏥 Medical Devices
• Categories: Implants & Prosthetics

Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, 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 surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.

Class I - Dangerous

The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.

Feb 14, 2019 Implants & Prosthetics Nationwide View Details →

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 surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.

Class I - Dangerous

The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.

Feb 14, 2019 Implants & Prosthetics Nationwide View Details →