Z-1407-2017Class II

MicroAire K-Wires

Name: Z-1407-2017 MicroAire K-Wires
Creator: MicroAire Surgical Instruments, LLC
Published: 2017-02-21
License: https://open.fda.gov/license/

MicroAire Surgical Instruments, LLC / initiated 2017-02-21 / Terminated / root cause: labeling and UDI

FDA source

MicroAire Surgical Instruments, LLC began a recall of MicroAire K-Wires on 2017-02-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1407-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-21
Posted: 2017-03-03
Terminated: 2017-07-14
Recalling firm: MicroAire Surgical Instruments, LLC
Product: MicroAire K-Wires
Product code: HTY Pin, Fixation, Smooth
Reason for recall: 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).
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The firm will mail recall letters to the customers who received the mislabeled k-wires on February 21, 2017. Letters will be sent by UPS to expedite the delivery. The firm will contact the non-responding accounts at least two more times.
Quantity in commerce: Total 362
Distribution: United States.
Product codes and lots: Part Number, Lot Number, Quantity Distributed to Field 1600-9355NS, 61005, 56; 1600-9625NS, 60297, 209; 1604-162NS, 62856, 97.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1407-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1407-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-03

Product code HTY

K863734Class IISteinmann(threaded/calibrated),knowles&hogie PinsMicro-Aire Surgical Instruments, Inc. / cleared 1986-10-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)