Surgical Instrument Service And Savings Recalls Carpal Tunnel Release Blades
Surgical Instrument Service And Savings, Inc. is recalling specific carpal tunnel release blades and kits because the sterile barrier seal was compromised, potentially 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. The hazard involves a compromised sterile barrier, which is a significant quality issue but does not involve reported injuries, deaths, or high-risk pathogens like Listeria or E. coli, fitting the Moderate category for low-risk contamination or precautionary recalls.
Plain-English summary
Surgical Instrument Service And Savings, Inc. is recalling 56 units of various carpal tunnel release blades and kits, including Instratek, Linvatec, Biomet Indiana, and KMI SafeGuard products. The recall covers specific reference numbers and lot numbers, including 122279, 122493, 122504, 122609, 122669, and 123190.
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 sterility. The affected products were distributed nationwide.
Healthcare providers and consumers should stop using these specific lots of carpal tunnel release blades and kits. The source text does not specify a particular consumer action beyond the recall notice, but standard protocol for compromised sterile barriers involves discontinuing use and contacting the manufacturer or distributor for replacement or refund.
The recalled product
- Product
- -Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279 -Instratek Carpal Tunnel Release Hook Blade. REF 2055 Lot 122669 -Linvatec CTS Relief Kit. REF 9971, lot 122504 -Biomet Indiana Tome Blade for Carpal Tunnel Release…
- Manufacturer
- Surgical Instrument Service And Savings, Inc.
- Hazard
- Affected units
- 56
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)
- 122279
- 122493
- 122504
- 122609
- 122669
- 123190
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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