Columbia, MD, United States
ACell, Inc recalls
1 recall recorded since 2018, most recently on 14 February 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 14 February 2019
- Terminated
- 7 May 2020
- Reason
- The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
- Distribution
- US nationwide distribution in the state of CA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1033-2019, Z-1032-2019
- 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 requiri
- 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 requiri
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.