FDAFDA · Food and drugs·Recall number Z-1644-2013
Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref. ACE36E Lot 122295, 122308, 122762 Unclassified
Published July 10, 2013 · Recall initiated: May 3, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Surgical Instrument Service And Savings, Inc.
- Distributor
- Nationwide Distribution.
- Lot
- 122295, 122308, 122762.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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