Greatbatch Medical

FDA Regulatory Profile

Summary

Total Recalls
16 (2 Class I)
510(k) Clearances
0
Inspections
9
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2055-2017Class IILinear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-1April 23, 2017
Z-2782-2017Class IIBiosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (laFebruary 15, 2017
Z-2781-2017Class IIViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006November 11, 2016
Z-1190-2017Class IIOffset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable surgical instrumentsOctober 19, 2016
Z-0623-2017Class IIGreatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-IntroducSeptember 8, 2016
Z-0367-2017Class IGreatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 TAugust 2, 2016
Z-1883-2016Class IITorque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. April 26, 2016
Z-1882-2016Class IITorque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: Customer Number/Model: April 26, 2016
Z-1884-2016Class IITorque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMEApril 26, 2016
Z-1614-2014Class IICoaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part DescriApril 28, 2014
Z-1119-2014Class IGreatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T104January 31, 2014
Z-1608-2013Class IICordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer GrMay 31, 2013
Z-0751-2013Class II45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model #: P2January 16, 2013
Z-0611-2013Class IIBiosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large CurNovember 12, 2012
Z-0132-2013Class IIBiosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large CurSeptember 24, 2012
Z-2459-2012Class IIBoston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston ScientiSeptember 6, 2012