Surgical Instrument Service Recalls Arthroscopic Electrodes Due to Seal Compromise
Surgical Instrument Service and Savings, Inc. is recalling 447 units of arthroscopic electrodes and wands 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 precautionary recall.
Plain-English summary
Surgical Instrument Service and Savings, Inc. is recalling 447 units of various arthroscopic electrodes, wands, and probes, including the 90 Degree L-Hook Tip Arthroscopic Electrode, Acromioplasty Electrode, and multiple VAPR and ArthroWand models. The recall covers specific lot numbers distributed nationwide.
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.
Healthcare facilities and consumers who have these specific devices should stop using them and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- -90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 7205441 Lot 122502 -Acromioplasty Electrode (Grey) 6.5" x 165mm. Ref. C5012A Lot 122288 -CAPSure 30 ArthroWand, CW, 30 Degree Shaft Angle, (Grey) 3.0mm. Ref. AC 1830-01 Lot…
- Manufacturer
- Surgical Instrument Service And Savings, Inc.
- Hazard
- Affected units
- 447
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 (20)
- 122029
- 122295
- 122486
- 122577
- 122734
- 122654
- 123266
- 122651
- 122427
- 122630
- 122494
- 122595
- 122419
- 122446
- 122308
- 122671
- 122455
- 122593
- 122626
- 122483
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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