Z-1119-2014Class I

Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T10491, T10507...

Name: Z-1119-2014 Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T10491, T10507...
Creator: Greatbatch Medical
Published: 2014-01-31
License: https://open.fda.gov/license/

Greatbatch Medical / initiated 2014-01-31 / Terminated / root cause: manufacturing process

FDA source

Greatbatch Medical began a recall of Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T10491, T10507, T10600, T10604, T10753, T10861, T11209, T11340... on 2014-01-31. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1119-2014
Classification: Class I
Status: Terminated
Initiated: 2014-01-31
Posted: 2014-03-06
Terminated: 2016-10-31
Recalling firm: Greatbatch Medical
Product: 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.
Product code: HWA Impactor
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Greatbatch sent an Urgent Medical Device Field Corrective Action letter dated January 31, 2014, to all affected consignees. The letter was addressed to "Dear Valued Customer". The letter described the Reason for Field Corrective Action, Risk to Health, and Instructions to Customers. The instructions to customers included to review the enclosed Field Corrective Action Response Form, to examine their inventory and identify all Standard Offset Cup Impactors that are in their possession and immediately inform those responsible for sterilization to utilize the updated instructions. Also, advised consignees to immediately notify all customers of the Field Corrective Action and to complete and return the Field Corrective Action Response Form. For questions consignees were instructed to contact their local Greatbatch Medical representative at 1-763-951-8235 or e-mail them at [email protected]. For questions regarding this recall call 763-951-8235. UPDATED 3-28-2014: An updated Urgent Medical Device Correction letter was sent out to consignees 3/28/2014 to tell them of an additional validated sterilization parameter in addition to additional devices that are affected by the recall. A notice was asked to be posted where sterilization of the Standard Offset Cup Impactors occurs so personnel responsible for the sterilization of the devices would see the 2 validated cycles. A response form was asked to be returned to Greatbatch.
Quantity in commerce: 4870 worldwide (2482 US), EXPANDED: 7245 devices
Distribution: 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.
Product codes and lots: all lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1119-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1119-2014	Class I	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-06

Product code HWA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)