Home / Recalls / Medical Devices
Surgical Instrument Service And Savings, Inc. recalls Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref. ACE36E Lot 122
Recalled July 10, 2013 · FDA recall Z-1644-2013 · Surgical Instrument Service And Savings
Hazard
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. · FDA Class II
Units
3
Sold at
Nationwide Distribution.
Description
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Product
Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref. ACE36E Lot 122295, 122308, 122762 Unclassified
Manufacturer(s)
Surgical Instrument Service And Savings, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →