Marco Shoulder Stabilization Kit Recall Due to Sterilization Failure
Aspen Surgical Products is recalling 4,270 Marco Shoulder Stabilization Kits manufactured between July 2019 and July 2021 due to bioburden levels exceeding sterilization validation limits, which may compromise sterile fields and increase infection risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a risk-of-harm medical device (sterilization failure) where no illnesses or injuries have been reported, placing it at the High severity level per the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Aspen Surgical Products is recalling 4,270 Marco Shoulder Stabilization Kits (Product Code 711100) manufactured between July 9, 2019 and July 9, 2021. The recall affects all lots produced during this period and were distributed nationwide in the United States.
The affected products were manufactured with materials that had bioburden levels exceeding the validated sterilization limits. As a result, the firm cannot provide assurance that the affected products were effectively sterilized and may not be safe for use.
The product may compromise the sterile field during surgical procedures and increase the risk of surgical site infection. Healthcare providers and patients using or about to use these products should be aware of this risk.
The recalled product
- Product
- Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100
- Manufacturer
- Aspen Surgical Products, Inc.
- Affected units
- 4,270
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- All lots manufactured between July 9
- 2019 to July 9
- 2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Aspen Surgical Products, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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