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.
Recall
- Recall Number
- Z-1032-2019
- Event Number
- 82228
- Firm
- ACell, Inc
- FEI Number
- 3005920706
- Product Code
- FTM
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- February 14, 2019
- Terminated
- May 7, 2020
- Address
- 6640 Eli Whitney Dr, Ste 200, Columbia, MD, 21046-2626
Description
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.
The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
Urgent Medical Device Recall notification letters dated 2/14/19 were sent to customers.
US nationwide distribution in the state of CA.
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