FDA Device recall Z-2389-2021
Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100
- FDA Device
- Class II
- terminated
- Published 2021-09-08
On 2021-09-08 the FDA classified a Class II recall of Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100 by Aspen Surgical Products, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2389-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-23 |
| Published | 2021-09-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Aspen Surgical Products |
| Distribution | US |
Product
Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100
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.
Identifiers
| code_info | All lots manufactured between July 9, 2019 to July 9, 2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2389-2021%22
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