Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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 1648-609 1624-509 1648-609T 1624-509T 1628-509 1632-509 1632-609 A smooth or threaded wire / pin that may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

FDA Recall Z-2159-2013 · Posted 2013-09-04

Recalling FirmMicroAire Surgical Instruments, LLC
Recall StatusTerminated
Product CodeHTY
Date Initiated2013-08-12
Date Terminated2014-02-12
Product Quantity15786 total units

Reason for Recall

A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility

Firm 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 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

Distribution Pattern

Worldwide Distribution - USA (nationwide) and internationally to Australia, Ireland, Canada, Netherlands, Sweden, Japan, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K863764COTTON ROLLS, NON-STERILEThe Medical Group, Inc. · 1986-10-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑