The Recall Desk
ModerateFDA (Devices)·Z-1633-2013·Announced 2013-07-10

Surgical Instrument Service And Savings Recalls 907 Arthroscopic Instruments

Surgical Instrument Service And Savings, Inc. is recalling 907 arthroscopic instruments because compromised sterile seals may allow product to fall out of the 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 involves a compromised sterile barrier which poses a risk of contamination, but the source text does not report any hospitalizations, serious injuries, or deaths, fitting the criteria for a moderate severity recall.

Plain-English summary

Surgical Instrument Service And Savings, Inc. is recalling 907 units of various arthroscopic instruments, including burs, cutters, dissectors, and blades. The recall is due to a defect where the seal that maintains a sterile barrier for reprocessed medical devices became compromised. This defect may allow the product to fall out of the pouch.

The affected products were distributed nationwide. The source text does not specify the number of illnesses or injuries associated with this recall. Consumers and healthcare facilities should stop using the affected lots and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
- Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270 - AcromioBlaster Burr (Brick Red) 5.5mm Ref. 7205669 Lot 122590, 122454, 122465, 122434, 122665 - AcromioBlaster Burr (Sage Green) 4.0mm Ref. 7205668 Lot 122590, 123270 - Acromionizer Bur, Barrel, (Mauve) 4.0mm Re
Affected units
907

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)

  • 122590
  • 122338
  • 123263
  • 122347
  • 123190
  • 122493
  • 122594
  • 122592
  • 122482
  • 122490
  • 122631
  • 122289
  • 123353
  • 122609
  • 122465
  • 122440
  • 123270
  • 122588
  • 122518
  • 122309

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 →