Device product
Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
Z-0989-2014
Product summary
- Firm
- Aesculap, Inc.
- Event
- Event 67174
- Status
- Terminated
- Classification
- Class II
- Quantity
- 79
- Official record key
device-enforcement:Z-0989-2014
Official wording
Reason: The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.
Code information: 4 lots: 4505268906, 4505336973, 4505408485, 4505238953
Distribution pattern: Worldwide Distribution - US Distribution including the states of AZ, MD, MA, WI, MI, MN, DE, KS, and FL., and the countries of Australia, Germany, Great Britain, Norway and Japan.
Derived failure modes
-
Potency or specification failure
out of specification