Surgical Instrument Service And Savings Recalls Arthroscopic Cannulas Due to Seal Defect
Surgical Instrument Service And Savings, Inc. is recalling 73 arthroscopic cannulas because a compromised seal may allow the product to fall out of the sterile pouch.
What this means for you
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 is a compromised sterile barrier, which is a significant quality issue but does not involve reported injuries or deaths, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Surgical Instrument Service And Savings, Inc. is recalling 73 units of various arthroscopic cannulas, including CLEAR-TRAC, Crystal, Dry-Doc, Instrument, PassPort, Smooth Clear, Threaded Clear, Tibial Tunnel, Twist-In, and Universal models. The recall is due to a defect in the seal that maintains the sterile barrier for these reprocessed medical devices.
The seal became compromised to the point where the product may fall out of the pouch. This defect poses a risk to the sterility of the devices. The affected products were distributed nationwide.
Consumers and healthcare facilities should stop using the affected cannulas and contact the recalling firm for instructions on return or replacement. The recall number is Z-1641-2013.
The recalled product
- Product
- - CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905 Lot 122631, 122609 - CLEAR-TRAC Flexible Cannula System Threaded, w/Obturator, (Lime Green) 8.0mm x 72mm Ref. 72200425 Lot 122631 - CLEAR-TRAC Flexible Cannula, Threaded, w/Obturator,
- Manufacturer
- Surgical Instrument Service And Savings, Inc.
- Hazard
- Affected units
- 73
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 (17)
- 122590
- 123263
- 123190
- 122504
- 122493
- 122594
- 123043
- 122631
- 122609
- 122465
- 122440
- 122588
- 122518
- 122279
- 122278
- 122434
- 122665.
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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