Home / Recalls / Greatbatch Medical / Z-1119-2014

Z-1119-2014 Class I Terminated

Recalled by Greatbatch Medical — Minneapolis, MN

FDA device recall Z-1119-2014 was initiated by Greatbatch Medical on January 31, 2014 and is designated Class I. Reason for recall: Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Impactor since the product was first released in 2004. Greatbatch has identified through internal Steri… The recall status is terminated (terminated October 31, 2016). Affected quantity: 4870 worldwide (2482 US), EXPANDED: 7245 devices.

Recall Details

Product Type
Devices
Report Date
March 12, 2014
Initiation Date
January 31, 2014
Termination Date
October 31, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4870 worldwide (2482 US), EXPANDED: 7245 devices

Product Description

Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T10491, T10507, T10600, T10604, T10753, T10861, T11209, T11340, T12121, T12230, T12288, T12305, T12391, T12699, T12767, T12861, T13344, T13480, T13642, T13722, T13999, T14155, T14384, T15311, T15752, T15822, T15949, T16117, T16427, T16604, T16611, T16661, T16829, T16934, T17062, T17203, T17238, T17321, T6318, T7821, T8042, T8043, T8044, T8087, T8088, T8093, T8095, T8177, T8184, T8277, T8310, T8333, T8468, T8487, T9109, T9196, T9205, T9316, T9348, T9360, T9556, T9557, T9747, T9894, T9954, T9955, T9999. The Standard Offset Cup Impactor is a reusable instrument used during acetabular replacement surgery to implant an acetabular cup. The Standard Offset Cup Impactor is provided non-sterile and must be sterilized prior to use in a surgery. The Standard Offset Cup Impactor is used to implant cups during many minimally invasive surgical approaches to Total Hip Arthroplasty ( ri-IA). EXPANDED 3-28-2014: The following Part Numbers are also affected: P10270, P6427, P6464, P6501, P7611, P7640, P7794, P7927, P8233, P8590, T10006, T10261, T10606, T10835, T11095, T11506, T11622, T12081, T12083, T12124, T12125, T13435, T13527, T14174, T15262, T15515, T16418, T16551, T16552, T16553, T17272, T5709, T6744, T7751, T9195.

Reason for Recall

Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Impactor since the product was first released in 2004. Greatbatch has identified through internal Sterility Assurance Level validation testing that a sterility assurance level of 10-6 is not achieved on the Standard Offset Cup Impactor when it is subjected to the steam sterilization cycles and associated dry times that are specified in the current Instructions For Use (IFU) provided with the device. The Standard Offset Cup Impactor is provided non-sterile and must be sterilized prior to use in a surgery. Greatbatch has not received any reports of deaths, illnesses, injuries, or other adverse effects associated with this issue.

Distribution Pattern

Worldwide Distribution - USA including CA, IN, KS, MA, NJ, TN,TX,UT and Internationally to Australia, Austria, Belgium, China, France, Germany, Greece, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.

Code Information

all lots

Other recalls by Greatbatch Medical

  • Z-2055-2017 Class II — Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgi (April 23, 2017)
  • Z-2782-2017 Class II — Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small cu (February 15, 2017)
  • Z-2781-2017 Class II — ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006 (November 11, 2016)
  • Z-1190-2017 Class II — Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable (October 19, 2016)
  • Z-0623-2017 Class II — Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Co (September 8, 2016)
  • Z-0367-2017 Class I — Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl06 (August 2, 2016)
  • Z-1882-2016 Class II — Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: Cus (April 26, 2016)
  • Z-1883-2016 Class II — Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non (April 26, 2016)
  • Z-1884-2016 Class II — Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed b (April 26, 2016)
  • Z-1614-2014 Class II — Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Orde (April 28, 2014)

FDA data resources