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U.S. Department of Health and Human Services

Class 2 Device Recall Taperlock

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  Class 2 Device Recall Taperlock see related information
Date Initiated by Firm January 13, 2004
Date Posted July 23, 2004
Recall Status1 Terminated 3 on September 01, 2004
Recall Number Z-1145-04
Recall Event ID 28217
Product Classification Implant, Endosseous, Root-Form - Product Code DZE
Product Taperlock Implant Line
Code Information Taperlock Implant Line    Part # Description Lot Number Quantity DTX/4 Xfr, Direct, Ext Hex Imp, 4.5mm 013389 80 DTX/4 Xfr, Direct, Ext Hex Imp, 4.5mm 014246 65 DTX/4 Xfr, Direct, Ext Hex Imp, 4.5mm 014838 164 DTX/4 Xfr, Direct, Ext Hex Imp, 4.5mm 016187 250 DTX/4 Xfr, Direct, Ext Hex Imp, 4.5mm 016747 86 DTX/4 Xfr, Direct, Ext Hex Imp, 4.5mm 0202572 99 IAX Analog, Imp, Ext Hex 014247 400 IAX Analog, Imp, Ext Hex 014248 256 ITX/4 Xfr, Indirect, Ext Hex Imp, 4.5mm Flare 014491 50 ITX/4 Xfr, Indirect, Ext Hex Imp, 4.5mm Flare 015558 70 ITX/4 Xfr, Indirect, Ext Hex Imp, 4.5mm Flare 017544 52 ITX/4 Xfr, Indirect, Ext Hex Imp, 4.5mm Flare 0202426 50 ITX/4 Xfr, Indirect, Ext Hex Imp, 4.5mm Flare 0202686 70 ITX/6 Xfr, Indirect, Ext Hex Imp, 6.5mm Flare 014476 50 THCX3/4 Healing Collar, Ti, Ext Hex Imp, 3mm, 4.5mm Flare 013086 110 THCX3/4 Healing Collar, Ti, Ext Hex Imp, 3mm, 4.5mm Flare 014251 300 THCX3/4 Healing Collar, Ti, Ext Hex Imp, 3mm, 4.5mm Flare 015122 184 THCX3/5 Healing Collar, Ti, Ext Hex Imp, 3mm, 5.5mm Flare 013276 98 THCX3/5 Healing Collar, Ti, Ext Hex Imp, 3mm, 5.5mm Flare 015118 149 THCX5/4 Healing Collar, Ti, Ext Hex Imp, 5mm, 4.5mm Flare 015221 257 THCX5/5 Healing Collar, Ti, Ext Hex Imp, 5mm, 5.5mm Flare 012928 100 THCX5/5 Healing Collar, Ti, Ext Hex Imp, 5mm, 5.5mm Flare 014536 85 TLB10 Impl, Scr, Taper-Lock, SBM, 4mm, 10mm 015538 169 TLB10 Impl, Scr, Taper-Lock, SBM, 4mm, 10mm 0201547 225 TLB10 Impl, Scr, Taper-Lock, SBM, 4mm, 10mm 0202622 96 TLB13 Impl, Scr, Taper-Lock, SBM, 4mm, 13mm 012905 297 TLB13 Impl, Scr, Taper-Lock, SBM, 4mm, 13mm 013744 113 TLB13 Impl, Scr, Taper-Lock, SBM, 4mm, 13mm 015539 310 TLB13 Impl, Scr, Taper-Lock, SBM, 4mm, 13mm 0202562 90 TLB13 Impl, Scr, Taper-Lock, SBM, 4mm, 13mm 0202728 195 TLB16 Impl, Scr, Taper-Lock, SBM, 4mm, 16mm 0201548 99 TLB16 Impl, Scr, Taper-Lock, SBM, 4mm, 16mm 0202949 96 TLB8 Impl, Scr, Taper-Lock, SBM, 4mm, 8mm 013743 81 TLB8 Impl, Scr, Taper-Lock, SBM, 4mm, 8mm 016755 136 TLH10 Impl, Scr, Taper-Lock, HA, 4mm, 10mm 014722 101 TLH10 Impl, Scr, Taper-Lock, HA, 4mm, 10mm 015540 95 TLH10 Impl, Scr, Taper-Lock, HA, 4mm, 10mm 0200510 125 TLH10 Impl, Scr, Taper-Lock, HA, 4mm, 10mm 0201616 95 TLH10 Impl, Scr, Taper-Lock, HA, 4mm, 10mm 0203101 396 TLH13 Impl, Scr, Taper-Lock, HA, 4mm, 13mm 013090 166 TLH13 Impl, Scr, Taper-Lock, HA, 4mm, 13mm 013203 79 TLH13 Impl, Scr, Taper-Lock, HA, 4mm, 13mm 013837 344 TLH13 Impl, Scr, Taper-Lock, HA, 4mm, 13mm 014097 120 TLH13 Impl, Scr, Taper-Lock, HA, 4mm, 13mm 015422 88 TLH13 Impl, Scr, Taper-Lock, HA, 4mm, 13mm 015808 84 TLH13 Impl, Scr, Taper-Lock, HA, 4mm, 13mm 016808 117 TLH13 Impl, Scr, Taper-Lock, HA, 4mm, 13mm 017259 100 TLH13 Impl, Scr, Taper-Lock, HA, 4mm, 13mm 017259 361 TLH16 Impl, Scr, Taper-Lock, HA, 4mm, 16mm 016756 97 TLH8 Impl, Scr, Taper-Lock, HA, 4mm, 8mm 014273 101 TLH8 Impl, Scr, Taper-Lock, HA, 4mm, 8mm 0203102 100 TLMB10 Impl, Scr, Taper-Lock, SBM, 3.3mm, 4mm, 10mm 013170 99 TLMB10 Impl, Scr, Taper-Lock, SBM, 3.3mm, 4mm, 10mm 014280 148 TLMB10 Impl, Scr, Taper-Lock, SBM, 3.3mm, 4mm, 10mm 0200704 100 TLMB10 Impl, Scr, Taper-Lock, SBM, 3.3mm, 4mm, 10mm 0201018 89 TLMB13 Impl, Scr, Taper-Lock, SBM, 3.3mm, 4mm, 13mm 012367 209 TLMB13 Impl, Scr, Taper-Lock, SBM, 3.3mm, 4mm, 13mm 015543 240 TLMB13 Impl, Scr, Taper-Lock, SBM, 3.3mm, 4mm, 13mm 0202873 147 TLMB8 Impl, Scr, Taper-Lock, SBM, 3.3mm, 4mm, 8mm 0201502 50 TLMH10 Impl, Scr, Taper-Lock, HA, 3.3mm, 4mm, 10mm 015541 122 TLMH13 Impl, Scr, Taper-Lock, HA, 3.3mm, 4mm, 13mm 016376 85 TLMH13 Impl, Scr, Taper-Lock, HA, 3.3mm, 4mm, 13mm 017309 98 TLMH13 Impl, Scr, Taper-Lock, HA, 3.3mm, 4mm, 13mm 0200104 118 TLMH16 Impl, Scr, Taper-Lock, HA, 3.3mm, 4mm, 16mm 014978 94 TLMH16 Impl, Scr, Taper-Lock, HA, 3.3mm, 4mm, 16mm 0202432 99 TLMH8 Impl, Scr, Taper-Lock, HA, 3.3mm, 4mm, 8mm 0200887 38 TLRT2 Tool, Removal, Int Hex Imp, Friction-Fit Abut, SST 014507 200 TLRT2 Tool, Removal, Int Hex Imp, Friction-Fit Abut, SST 015089 349 TLRT2 Tool, Removal, Int Hex Imp, Friction-Fit Abut, SST 016688 400 TLRT2 Tool, Removal, Int Hex Imp, Friction-Fit Abut, SST 016964 296 TLSD Drill, Twist Tri-Spade, Taper-Lock Scr, 3.5mm, 17m 012057 174 TLSD Drill, Twist Tri-Spade, Taper-Lock Scr, 3.5mm, 17m 014770 150 TLSDS DRILL,3.5MM,11MM 011972 67 TLSDS DRILL,3.5MM,11MM 013356 190 TLSMD16 Drill, Twist Tri-Spade, T-L, C''sink, 2.8mm, 16mm 011973 53 TLSMD8 Drill, Twist Tri-Spade, T-L, C''sink, 2.8mm, 8mm 012052 150 TLSMD8 Drill, Twist Tri-Spade, T-L, C''sink, 2.8mm, 8mm 015791 51 TLWB13 Impl, Scr, Taper-Lock, SBM, 4.7mm, 4mm, 13mm 015544 147 TLWB16 Impl, Scr, Taper-Lock, SBM, 4.7mm, 4mm, 16mm 0202816 69 TLWB8 Impl, Scr, Taper-Lock, SBM, 4.7mm, 4mm, 8mm 012927 107 TLWH10 Impl, Scr, Taper-Lock, HA, 4.7mm, 4mm, 10mm 013302 245 TLWH10 Impl, Scr, Taper-Lock, HA, 4.7mm, 4mm, 10mm 0200120 103 TLWH10 Impl, Scr, Taper-Lock, HA, 4.7mm, 4mm, 10mm 0203192 41 TLWH13 Impl, Scr, Taper-Lock, HA, 4.7mm, 4mm, 13mm 015545 89 TLWH13 Impl, Scr, Taper-Lock, HA, 4.7mm, 4mm, 13mm 016918 95 TLWH16 Impl, Scr, Taper-Lock, HA, 4.7mm, 4mm, 16mm 016789 50 TLWH8 Impl, Scr, Taper-Lock, HA, 4.7mm, 4mm, 8mm 014535 40 TLWH8 Impl, Scr, Taper-Lock, HA, 4.7mm, 4mm, 8mm 017136 50 
Recalling Firm/
Manufacturer		 Zimmer Dental Inc
1900 Aston Ave
Carlsbad CA 92008-7308
Manufacturer Reason
for Recall		 Sterility barrier compromised.
FDA Determined
Cause 2		 Other
Quantity in Commerce See Codes
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.
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