Recall Z-2158-2013— MicroAire Surgical Instruments, LLC

Name: FDA recall Z-2158-2013
Creator: U.S. Food and Drug Administration
Published: 2013-08-12

Class II · Terminated

Class II FDA medical device recall by MicroAire Surgical Instruments, LLC, initiated 2013-08-12, terminated 2014-02-12. It names one FDA 510(k) clearance: K863764. Product: Steinmann Pin, 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.. Reason: A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility.

Recalling firm: MicroAire Surgical Instruments, LLC
Classification: Class II
Status: Terminated
Initiated: 2013-08-12
Terminated: 2014-02-12
Firm location: Charlottesville, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K863764 — COTTON ROLLS, NON-STERILEThe Medical Group, Inc.·cleared 1986-10-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Steinmann Pin, 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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.