FDA-Device2013-07-10Class II

Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref. ACE36E Lot 122295, 122308, 122762 Unclassified

Surgical Instrument Service And Savings, Inc.
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.

Sold states
Nationwide Distribution.
Affected count
3
Manufactured in
2747 Sw 6th St, N/A, Redmond, OR, United States
Products
Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref. ACE36E Lot 122295, 122308, 122762 Unclassified

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1644-2013

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