FDA Medical Device Recalls (openFDA)
ACell, Inc: 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.
- Recall number
- Z-1033-2019
- Recalling firm
- ACell, Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2019-02-14
- Posted
- not on file
- Terminated
- 2020-05-07
- Reason
- The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
- Root cause
- Nonconforming Material/Component
- Action
- Urgent Medical Device Recall notification letters dated 2/14/19 were sent to customers.
- Quantity
- 1
- Distribution
- US nationwide distribution in the state of CA.
- Lot, serial or model codes
- SN KJ000423
- 510(k) numbers
- ["K170763"]
- PMA numbers
- not on file
- Product code
- FTM
- Firm FEI
- 3005920706
- Firm city
- Columbia
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28