Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales
FDA device recall Z-2159-2013 · posted 2013-09-04 · Terminated
Recall details
- Recalling firm
- MicroAire Surgical Instruments, LLC
- Reason for recall
- A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility
- Action taken
- 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 does not make it into the surgical process. Customers with questions were instructed to call 434-975-8370. For questions regarding this recall call 434-975-8370.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- HTY
- Quantity affected
- 15786 total units
- Distribution
- Worldwide Distribution - USA (nationwide) and internationally to Australia, Ireland, Canada, Netherlands, Sweden, Japan, and United Kingdom.
- Date initiated
- 2013-08-12
- Date posted
- 2013-09-04
- Date terminated
- 2014-02-12
- Location
- Charlottesville, VA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COTTON ROLLS, NON-STERILE (K863764) | The Medical Group, Inc. | 1986-10-27 |