Z-1033-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 27, 2019
- Initiation Date
- February 14, 2019
- Termination Date
- May 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
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.
Reason for Recall
The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
Distribution Pattern
US nationwide distribution in the state of CA.
Code Information
SN KJ000423