Recall Z-1439-2013— Gyrus Acmi, Incorporated

Name: FDA recall Z-1439-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-24

Class II · Terminated

Class II FDA medical device recall by Gyrus Acmi, Incorporated, initiated 2013-05-24, terminated 2014-05-30. FDA's recall record names no specific 510(k) clearance for this event. Product: GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear.. Reason: lack of sterility assurance.

Recalling firm: Gyrus Acmi, Incorporated
Classification: Class II
Status: Terminated
Initiated: 2013-05-24
Terminated: 2014-05-30
Firm location: Southborough, MA, United States

Product description

GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear.

Reason for recall

lack of sterility assurance

Data sourced from openFDA. This site is unofficial and independent of the FDA.