Surgical Instrument Service And Savings Recalls 15 Suture Instruments
Surgical Instrument Service And Savings, Inc. is recalling 15 suture instruments because compromised seals may allow the sterile barrier to fail.
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 potential loss of sterility without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Surgical Instrument Service And Savings, Inc. is recalling 15 units of manual surgical instruments, specifically suture hooks and suture lassos, manufactured by ConMed Linvatec and Arthrex. The affected products include specific lots of the Spectrum II Suture Hook Crescent and various models of the SutureLasso SD and SutureLasso instruments.
The recall was initiated because the seal that maintains a sterile barrier for these reprocessed medical devices became compromised. This defect may allow the product to fall out of the pouch, potentially compromising the sterility of the instruments. The products were distributed nationwide.
Consumers and healthcare facilities should stop using the affected suture instruments and contact Surgical Instrument Service And Savings, Inc. for further instructions or a replacement.
The recalled product
- Product
- - ConMed Linvatec Spectrum II Suture Hook Crescent, Medium (Teal) 4.0 x 20.0mm. REF C6386 Lot 122592. - Arthrex SutureLasso SD, 25 Degree Tight Curve Left, Wire Loop, (Green) 1.8mm. REF AR-4068-25TL Lot 122518 and Lot 123190. -- Arthrex SutureLasso SD, 25 Degree Tight…
- Manufacturer
- Surgical Instrument Service And Savings, Inc.
- Hazard
- Affected units
- 15
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 (6)
- 122504
- 122518
- 122590
- 122592
- 123190
- 123263.
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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