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U.S. Department of Health and Human Services

Class 1 Device Recall Offset Cup Impactor

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  Class 1 Device Recall Offset Cup Impactor see related information
Date Initiated by Firm January 31, 2014
Date Posted March 06, 2014
Recall Status1 Terminated 3 on October 31, 2016
Recall Number Z-1119-2014
Recall Event ID 67392
Product Classification Impactor - Product Code HWA
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.
Code Information all lots
Recalling Firm/
Greatbatch Medical
2300 Berkshire Ln N
Minneapolis MN 55441-4575
For Additional Information Contact
Manufacturer 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.
FDA Determined
Cause 2
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 FieldActionCenter@Greatbatch.com. 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.