Surgical Instrument Service And Savings Recalls 30 Surgical Instrument Motors and Accessories
Surgical Instrument Service And Savings, Inc. is recalling 30 surgical instrument motors and accessories because the sterile barrier seal may be compromised, allowing 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, and the hazard involves a compromised sterile barrier without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Surgical Instrument Service And Savings, Inc. is recalling 30 surgical instrument motors and accessories, including various drill bits, burs, and twist drills. The recall is due to a compromised seal that maintains a sterile barrier for reprocessed medical devices. This defect may allow the product to fall out of the pouch.
The affected products were distributed nationwide. Specific lot numbers involved in the recall include 122347, 122454, 122411, 122289, 123353, 122429, 122322, 122447, 122665, 122647, and 122511.
Consumers and healthcare facilities should stop using the affected products and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- - Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head: 7.5mm Dia. x 9.5mm Length Ref. 5130-30-75 Lot 122665 - Cannulated Drill Bit, for 3.0mm Cannulated Screws, 1.2mm Cannulation, Quick Coupling 2.0mm x 150mm Ref. 310.221 Lot 122289 - Drill Bit…
- Manufacturer
- Surgical Instrument Service And Savings, Inc.
- Affected units
- 30
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 (11)
- 122347
- 122454
- 122411
- 122289
- 123353
- 122429
- 122322
- 122447
- 122665
- 122647
- 122511.
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.
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