Recall Z-1644-2013— Surgical Instrument Service And Savings, Inc.

Name: FDA recall Z-1644-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-03

Class II · Terminated

Class II FDA medical device recall by Surgical Instrument Service And Savings, Inc., initiated 2013-05-03, terminated 2013-07-11. It names one FDA 510(k) clearance: K012669. Product: Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref. ACE36E Lot 122295, 122308, 122762 Unclassified. Reason: The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch..

Recalling firm: Surgical Instrument Service And Savings, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-05-03
Terminated: 2013-07-11
Firm location: Redmond, OR, United States

510(k) clearances named in this recall

1 on FDA's record

K012669 — REPROCESSED ELECTROSURGICAL ELECTRODESSurgical Instruments Service and Savings, Inc.·cleared 2002-06-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Data sourced from openFDA. This site is unofficial and independent of the FDA.