Marco Shoulder Stabilization Kit — Class II medical device recall Z-2389-2021
Terminated recall by Aspen Surgical Products, Inc., reported 2021-09-08, distributed nationwide. Affected products were manufactured with materials found to have a bioburden level exceeding the limit at whic
| Recall number | Z-2389-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aspen Surgical Products, Inc., Caledonia, MI, United States |
| Recall initiated | 2021-07-23 |
| Classified | 2021-08-30 |
| Reported by FDA | 2021-09-08 |
| Terminated | 2022-07-26 |
| Distributed | Nationwide (US) |
| Quantity | 4,270 |
| Reason classes | sterility |
Product
Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2389-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.