Norton Arm Kit surgical device recall due to sterilization failure
Aspen Surgical Products is recalling 124 Norton Arm Kits due to bioburden levels exceeding sterilization validation limits, creating potential risk of surgical site infection.
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: FDA Class II recall for surgical devices with bioburden exceeding sterilization validation limits. This creates a risk of surgical site infection from non-sterile products, meeting the criteria for High severity as a risk-of-harm product without reported injuries.
Plain-English summary
Aspen Surgical Products, Inc. is recalling Norton Arm Kits (Product Code 711400, Sample Kit S711400) manufactured between July 9, 2019 and July 9, 2021. These units were distributed nationwide in the United States.
The recalled products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. The firm cannot provide full assurance that the affected products were effectively sterilized.
Because sterility cannot be assured, the products may compromise a sterile field and increase the risk of surgical site infection. This affects 124 units total. There was no foreign distribution.
The recalled product
- Product
- Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400
- Manufacturer
- Aspen Surgical Products, Inc.
- Affected units
- 124
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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