Device 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.
Z-1439-2013
Product summary
- Event
- Event 65255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 boxes of 6 units
- Official record key
device-enforcement:Z-1439-2013
Official wording
Reason: lack of sterility assurance
Code information: JC477666
Distribution pattern: Worldwide Distribution - USA (nationwide) and countries of: Canada and United Kingdom.
Derived failure modes
-
Sterility assurance
lack of sterility