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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes

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 Class 2 Device Recall Synthessee related information
Date Initiated by FirmApril 29, 2014
Date PostedMay 29, 2014
Recall Status1 Terminated 3 on May 19, 2016
Recall NumberZ-1669-2014
Recall Event ID 68190
Product Classification Bit, surgical - Product Code GFG
ProductSynthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0mm Milling Bit with Flat Coupling. Spinal surgical instrument: The Synthes ProDisc-C 2.0mm Milling Bits are used as a part of the milling option for keel preparation of the vertebral bodies. The milling bits are coupled to a power tool and interface with the milling guide, which is connected to a trial implant for the keel preparation step.
Code Information part number: 03.820.161s, with lot numbers: 5742507,5755970,5755971,5755972, 5755973,5755974,5828298,6336115, 6338099,6338100,6340029,6340030, 6344199,6344200,6363601,6385892, 6407046,6431260,6431261,6460402, 6503360,6526127,6571070,6571073, 6571074,6601985,6636946,6636947, 6636948,6653819,6653820,6670383, 6691341,6691342,6718933,6718934, 6718935,6740611,6794651,6794652, 6794653,6794654,6794655  part number: 03.820.1638 with lot numbers: 5742506,5755978,5755979,5755980, 5755981,5755982,5828299,5828300, 6320586,6336108,6336110,6336111, 6340033,6344201,6344202,6363602, 6385893,6431262,6431263,6460403, 6503361,6571075,6601986,6601987, 6636949,6636950,6636951,6653810, 6653818,6670382,6691343,6691344, 6718938,6740615,6740616,6745821, 6770474,6770475,6770476,6770477, 6770478,6794657,6794658  part number: 03.820.167S with lot numbers:  5755983,5755984,5755987,5755988, 5755989,5755985,5755986,5755990, 5828302,6338101,6338102,6338103, 6338104,6338106,6338107,6338108, 6338109,6344205,6471089,6670381, 6718939,6718940,6718941,6843907, 6843906,6856252,6856253,6867662, 6867661,6901712,6901713,6919726, 6919727,6919728,6901710,6901711, 6921717,6921718,6940357,6960192, 6960193,6983033,7006496,7055427  part number: 03.820.169S with lot numbers: 6066520,6113671,6113633,6159883, 6180175,6338068,6338098,6344206, 6363603,6407047,6431264,6460404, 6526128,6571078,6670384,6745820, 6770479,6770480 
Recalling Firm/
Manufacturer		 Synthes, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information ContactCustomer Support
610-719-5000
Manufacturer Reason
for Recall		Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use.
FDA Determined
Cause 2		Process control
ActionDePuy Synthes sent a Recall letter, dated April 29, 2014, to affected customers. The letter identified the affected customers, problem and actions to be taken. The letter instructed customers to discontinue use and distribution of the device and to return affected devices to Synthes. For questions call 610-719-5450.
Quantity in Commerce6690
DistributionUS Nationwide Distribution
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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