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U.S. Department of Health and Human Services

Class 2 Device Recall T5766 Offset Reamer Handle

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 Class 2 Device Recall T5766 Offset Reamer Handlesee related information
Date Initiated by FirmOctober 19, 2016
Create DateFebruary 11, 2017
Recall Status1 Terminated 3 on March 08, 2019
Recall NumberZ-1190-2017
Recall Event ID 76236
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductOffset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable surgical instruments used in arthroplasty surgery of the hip joints, where either total joint replacement or resurfacing surgery is performed using a reamer cutting instrument. The reamer handles are intended for use with a surgical driver (active device). The reamer handle is connected at the distal end to a reamer. The T5766 reamer handle is an offset design with a drive shaft mechanism that spins on roller bearings and is encapsulated in an inner clam shell housing that is constrained within a Radel tube and outer housing.
Code Information 2481193, 2468380, 2599785, 2463309, 2468379, 2468398, 2468397, 2599516, 2671555, 2599517, 2670543, 2671558, 2734809, 2814828, 2814829, 2824496, 2858434, 2865404, 3030658, 2944397, 2977852, 2967214, 3000586, 3000590, 3030658, 3044689, 3071903, 3135658, 3088675, 3107504, 3188688, 3385844, 3188690, 3387046, 3397768.
Recalling Firm/
Manufacturer		 Greatbatch Medical
2300 Berkshire Ln N
Plymouth MN 55441-4575
For Additional Information ContactGreatbatch Medical representative
763-951-8100
Manufacturer Reason
for Recall		On June 14, 2016, Greatbatch discovered a significant increase in the number of field complaints for the T5766 Offset Reamer Handle in which the U-joints of the drive chain component seizes during orthopedic procedures rendering the device non-functional. The 2016 failure rate for this failure exceeds the occurrence rate as defined in the DFMEA.
FDA Determined
Cause 2		Device Design
ActionConsignee was sent via e-mail on 10/16/2016 a Greatbatch "Urgent Medical Device Recall" letter dated 10/19/2016 The letter described the purpose of the letter, Reason for Notification, Risk to Health, Recommendation, Instruction to Zimmer. Advised consignee to examine their inventory, quarantine the product and provide a list of the affected countries where the product was distributed. Also requested consignee to complete the Customer Notification Response form and return to Greatbatch at FieldActionCenter@Greatbatch.com. For questions contact your local Greatbatch Medical representative, Monday through Friday via telephone at 1-763-951-8235 8:00 AM (CT) to 5:00 PM (CT), or e-mail us at FieldActionCenter@Greatbatch.com .
Quantity in Commerce1,441
DistributionWorldwide Distribution - US Nationwide in the states of IN and the countries of Canada, Austria, Germany, Japan.
Total Product Life CycleTPLC 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.
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