Food, drugs, devices › MicroAire Surgical Instruments, LLC

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

FDA enforcement event 78687 · Class II · initiated 22 May 2017 · status Terminated · terminated 29 Aug 2018

DeviceVoluntary: Firm initiated1 product recordCharlottesville, VA

FDA enforcement event 78687 is a device recall by MicroAire Surgical Instruments, LLC of Charlottesville, VA, initiated 22 May 2017 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.

Status: Terminated, terminated 29 Aug 2018. Initiation: voluntary: firm initiated. MicroAire Surgical Instruments, LLC has 12 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

MicroAire Surgical Instruments, LLC, Charlottesville, VA.

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)"

Distribution

"US Distribution."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0412-2018	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	42	Class II	Terminated	7 Feb 2018

Context

93%of 2017 device events are Class II1,091 events that year

1product record in this eventfirm median: 1

12events on this register for the firm

Other enforcement events for MicroAire Surgical Instruments, LLC

Initiated	Product (first record)	Type	Class	Records
7 May 2025	Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endosc	Device	Class II	1
26 Jun 2019	SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014	Device	Class II	1
19 Apr 2018	MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev.	Device	Class II	1
21 Feb 2017	MicroAire K-Wires	Device	Class II	1
6 May 2016	Endotine Transbleph 3.5 (CFD-080-0167)	Device	Class II	1
11 Mar 2016	Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry	Device	Class II	1
8 Feb 2016	MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula	Device	Class II	1
8 Feb 2016	MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device	Device	Class II	1
12 Jun 2015	ASP-1020 LipoTower with Aspiration Pump. Medical use.	Device	Class II	2
12 Aug 2013	Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouc	Device	Class II	2

All 12 events for MicroAire Surgical Instruments, LLC

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm)"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US Distribution."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 29 Aug 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.