MicroAire K-Wires
FDA Recall Z-1407-2017 · Posted 2017-03-03
Recalling FirmMicroAire Surgical Instruments, LLC
Recall StatusTerminated
Product CodeHTY
Date Initiated2017-02-21
Date Terminated2017-07-14
Product QuantityTotal 362
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).
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
United States.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.