Recall Z-2389-2021— Aspen Surgical Products, Inc.
Class II · Terminated
Class II FDA medical device recall by Aspen Surgical Products, Inc., initiated 2021-07-23, terminated 2022-07-26. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Aspen Surgical Products, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-07-23
- Terminated
- 2022-07-26
- Firm location
- Caledonia, MI, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.