Harmonic ACE Ergonomically-Enhanced Curved Shear recall: Sterility Concern
Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref. ACE36E Lot 122295, 122308, 122762…
Why was Harmonic ACE Ergonomically-Enhanced Curved Shear 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
122295, 122308, 122762.
- Product
- Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref. ACE36E Lot 122295, 122308, 122762…
- Recalling firm
- Surgical Instrument Service And Savings, Inc.
- Quantity
- 3
- Distribution
- Nationwide Distribution.
- Recall date
- July 10, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)