Surgical Instrument Recall Due to Compromised Sterile Seal
Surgical Instrument Service And Savings is recalling Large Tear Cross Cut Rasps because the sterile seal may be compromised, allowing the product to fall out of the pouch.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a compromised sterile barrier, which is a significant quality issue, but the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity rating.
Plain-English summary
Surgical Instrument Service And Savings, Inc. is recalling two units of the Large Tear Cross Cut Rasp (14mm x 7mm, Ref. 5100-37-114, Lot 122347). These are manual surgical instruments intended for general use.
The recall was initiated because the seal that maintains a sterile barrier for the reprocessed medical devices became compromised. This defect may allow the product to fall out of the pouch, potentially compromising sterility.
The affected products were distributed nationwide. Users of these specific instruments should stop using them and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Large Tear Cross Cut Rasp 14mm x 7mm Ref. 5100-37-114 Lot 122347 Manual surgical instrument for general use
- Manufacturer
- Surgical Instrument Service And Savings, Inc.
- Hazard
- Affected units
- 2
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 (1)
- 122347
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Surgical Instrument Service And Savings, 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.
See all 22 products in this recall →Related recalls
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