Z-0412-2018Class II

SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in...

Name: Z-0412-2018 SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in...
Creator: MicroAire Surgical Instruments, LLC
Published: 2017-05-22
License: https://open.fda.gov/license/

MicroAire Surgical Instruments, LLC / initiated 2017-05-22 / Terminated / root cause: labeling and UDI

FDA source

MicroAire Surgical Instruments, LLC began a recall of SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large and small bone... on 2017-05-22. FDA classified it as Class II and gives the reason as "One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm)". 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-0412-2018
Classification: Class II
Status: Terminated
Initiated: 2017-05-22
Posted: 2018-01-26
Terminated: 2018-08-29
Recalling firm: MicroAire Surgical Instruments, LLC
Product: SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large and small bone surgeries) to cut bone
Product code: HTW Bit, Drill
Reason for recall: One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm)
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: MicroAire Surgical Instruments, LLC distributed recall letters on May 22, 2017 MicroAire Surgical Instruments, LLC distributed recall letters to the customers who received the mislabeled twist. Letters will be sent by UPS to expedite the delivery. For further questions, please call (434) 975-8000
Quantity in commerce: 42
Distribution: US Distribution.
Product codes and lots: LIT 0317305390

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0412-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0412-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-26

Product code HTW

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)