Microaire Surgical Instruments Llc

Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.

The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.

Mislabeling on three lots of K-Wires. The incorrect product description " dual trocar" instead of "single trocar" was on the product label on the following parts: 1600-9355NS (lot 61005), 1600-9625NS (lot 60297), and 1604-162NS (lot 62856).

MicroAire discovered that 20 suspect Impactor instruments ( MicroAire Pneumatic Impactor) were shipped to end users and were missing the lock and unlock symbol markings on them.

There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails.

There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails.

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

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

Medical device was not manufactured under Good Manufacturing Procedures and a user may be unable to sterilize the device according to procedures.

One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm)