Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Integer HoldingsLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Greatbatch Medical with 16 device recalls. The most recent is a device recall dated Apr 23, 2017: Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc.….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 23, 2017 | Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and EZ Clean" Linear Broach Handle Class II · Greatbatch Medical has voluntarily initiated a Recall for the Linear Straight Broach Handle (Rasp Handle) and EZ Clean" | Device recalls |
| Feb 15, 2017 | Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). The MobiCath Bi-DirectionClass II · One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed. | Device recalls |
| Nov 11, 2016 | ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006Class II · Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use. | Device recalls |
| Oct 19, 2016 | Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable surgical instruments used in arthroplasty surgery of the hipClass II · On June 14, 2016, Greatbatch discovered a significant increase in the number of field complaints for the T5766 Offset Re | Device recalls |
| Sep 8, 2016 | Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 Stiffer Coaxial Micro-Class II · Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR after a field complaint | Device recalls |
| Aug 2, 2016 | Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100CHAClass I · On December 17, 2015, Greatbatch discovered that the Standard Offset Cup Impactor with a POM-C handle grip failed steril | Device recalls |
| Apr 26, 2016 | Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, NonClass II · Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through labor | Device recalls |
| Apr 26, 2016 | Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: Customer Number/Model: MCL120014 T14000, TLT911-50-S20 TLClass II · Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through labor | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
