Reported Jul 10, 2013 · Terminated
- Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270 - AcromioBlaster Burr (Brick Red) 5.5mm Ref. 7205669 Lot…
Surgical Instrument Service And Savings, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Surgical Instrument Service And Savings, Inc. · 2747 Sw 6th St · Redmond, OR · 97756-7109
Is this the product you have?
49 of 49 products
| Model / number | Product as published |
|---|---|
7205669 | Lot 123270 - AcromioBlaster Burr (Brick Red) 5.5mm |
7205668 | Lot 122590, 122454, 122465, 122434, 122665 - AcromioBlaster Burr (Sage Green) 4.0mm |
7205326 | Lot 122590, 123270 - Acromionizer Bur, Barrel, (Mauve) 4.0mm |
7206010 | Lot 122609 - BoneCutter Blade, Full Radius, Series 3000 (Orange/Black) 5.5mm |
AR-8380BC | Lot 122609 - CoolCut Bone Cutter (Blue/Orange) 3.8mm |
AR-8400BC | Lot 122631 arthoscope - CoolCut Bone Cutter (Blue/Orange) 4.0mm |
AR-8550BC | Lot 122631 - CoolCut Bone Cutter (Blue/Orange) 5.5mm |
AR-8350DS | Lot 122631 - CoolCut Dissector (Blue/Blue) 3.5mm |
AR-8400DS | Lot 123190 - CoolCut Dissector (Blue/Blue) 4.0mm |
AR-8500DS | Lot 123190, 122493, 122631 - CoolCut Dissector (Blue/Blue) 5.0mm |
AR-7300DS | Lot 122493 - CoolCut Dissector Small Joint (Blue/Blue) 3.0mm |
AR-8380EX | Lot 123190, 122493, 122631, - CoolCut Excalibur (Blue/Beige) 3.8mm |
AR-8400EX | Lot 122631 - CoolCut Excalibur (Blue/Beige) 4.0mm |
AR-8550OBT | Lot 122631 - CoolCut Oval Burr (12 Flutes) (Blue/White) 5.5mm |
AR-8400OBE | Lot 122631 - CoolCut Oval Burr (8 Flute) (Blue/White) 4.0mm |
AR-8500OBE | Lot 122493, 122631, 122279 - CoolCut Oval Burr (8 Flute) (Blue/White) 5.0mm |
AR-8500RBE | Lot 122493 - CoolCut Round Burr (8 Flute) (Blue/Red) 5.0mm |
AR-8380SR | Lot 123190 - CoolCut Sabre (Blue/Green) 3.8mm |
72200730 | Lot 122493 - DYONICS ELITE Achromobacter (Sage Green) 4.0mm |
72200731 | Lot 122665 - Elite* AcromioBlaster Burr (Brick Red/Yellow) 5.5mm |
- Lot codes and dates
122590122338123263122347123190122493122594122592122482122490122631122289123353122609122465122440123270122588122518122309122279122278122434122665122511
- Amount recalled
- 907
This recall covers 22 products
The agency filed one notice per product. You are reading one of them; the other 21 are below.
9 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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