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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes

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 Class 2 Recall
Synthes
see related information
Date Posted May 29, 2014
Recall Status1 Open
Recall Number Z-1669-2014
Recall Event ID 68190
Product Classification Bit, Surgical - Product Code GFG
Product Synthes 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, Pennsylvania 19380-3417
For Additional Information Contact Customer 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
PRODUCTION CONTROLS: Process Control
Action DePuy 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 Commerce 6690
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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