Caledonia, MI, United States
Aspen Surgical Products, Inc. recalls
1 recall recorded since 2018, most recently on 23 July 2021. 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
- 23 July 2021
- Terminated
- 26 July 2022
- Reason
- Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.
- Distribution
- US nationwide distribution. No foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2390-2021, Z-2388-2021, Z-2389-2021
- Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400
- Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
- Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100
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.