Recall Z-1033-2019

ACell, Inc · initiated February 14, 2019

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

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.

Codes / lots: SN KJ000423

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.

FDA-determined cause: Nonconforming Material/Component

Action taken

Urgent Medical Device Recall notification letters dated 2/14/19 were sent to customers.

Details

Recall number
Z-1033-2019
Initiated
February 14, 2019
Terminated
May 7, 2020
Product code
FTM – Mesh, Surgical
Quantity
1
Distribution
US nationwide distribution in the state of CA.
Recalling firm
ACell, Inc, Columbia, MD

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1032-2019 Class IIGentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product…The devices were released from a lot for which one sample failed to meet the company' s tensile strength… 02/14/2019Terminated