Recall Z-1032-2019— ACell, Inc
Class II · Terminated
Class II FDA medical device recall by ACell, Inc, initiated 2019-02-14, terminated 2020-05-07. It names one FDA 510(k) clearance: K170763. 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 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: The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release..
- Recalling firm
- ACell, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-02-14
- Terminated
- 2020-05-07
- Firm location
- Columbia, MD, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.