Recall Z-2159-2013 ยท HTY Pin, Fixation, Smooth
MicroAire Surgical Instruments, LLC
Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-509 1620-509 1640-509 1620-609 1648-509 1620-709 1648-509T 1624-109 164
| Date | Sep 4, 2013 (initiated Aug 12, 2013) |
| Status | Terminated |
| Reason | A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility |
| Root cause | Packaging process control |
| Action | MicroAire Surgical LLC sent an Urgent Medical Device Recall letter dated August 12, 2013, to all affected customers. The letter advised consignees recover and quarantine the affected product so that it does not make it into the surgical process. Customers were instructed to either return affected product to MicroAire for inspection or they could inspect the product for the defect by looking at the seal area on the inside sterile package (short non-chevron side). The recalling firm further advised distributors to contact all of their customers to recover and quarantine the product so that it d |
| Quantity | 15786 total units |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to Australia, Ireland, Canada, Netherlands, Sweden, Japan, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K863764 | COTTON ROLLS, NON-STERILE The Medical Group, Inc., Oct 27, 1986 |