Orthopedic Manual Surgical Instrument

Device Code: 4601

Product Code(s): LXH

Device Classification Information

Device Type ID4601
Device NameOrthopedic Manual Surgical Instrument
Regulation DescriptionOrthopedic Manual Surgical Instrument.
Regulation Medical SpecialtyOrthopedic
Review PanelOrthopedic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Orthopedic Devices (DOD)
Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2)
Submission Type510(K) Exempt
CFR Regulation Number888.4540 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeLXH
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4601
DeviceOrthopedic Manual Surgical Instrument
Product CodeLXH
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOrthopedic Manual Surgical Instrument.
CFR Regulation Number888.4540 [🔎]
Premarket Reviews
ManufacturerDecision
ORTHOVITA
 
SUBSTANTIALLY EQUIVALENT
 1
STRYKER CORP.
 
SUBSTANTIALLY EQUIVALENT
 1
Device Problems
Break
 8239
Appropriate Term/Code Not Available
 1616
Fracture
 1465
Crack
 937
Device Operates Differently Than Expected
 494
Material Integrity Problem
 478
Dull, Blunt
 463
Mechanical Jam
 442
Naturally Worn
 440
Bent
 381
Component Missing
301
Mechanical Problem
 296
Material Deformation
 294
Insufficient Information
 292
Corroded
281
Scratched Material
 272
Material Fragmentation
 257
Device-Device Incompatibility
 248
Fitting Problem
 194
Tip
 183
Failure To Align
 172
Adverse Event Without Identified Device Or Use Problem
 163
Detachment Of Device Component
 159
Material Twisted / Bent
 153
Difficult To Remove
142
Disassembly
 126
Detachment Of Device Or Device Component
 113
Loose Or Intermittent Connection
 104
Device Contamination With Chemical Or Other Material
 90
Connection Problem
 85
Screw
 82
Material Discolored
 82
Sticking
 71
Separation Failure
62
Failure To Adhere Or Bond
 61
Use Of Device Problem
 54
Degraded
 54
Metal Shedding Debris
 46
Difficult To Insert
 45
Device Issue
 38
Handpiece
 38
Device Inoperable
 36
Device Dislodged Or Dislocated
 35
Physical Resistance / Sticking
 35
Device Slipped
 33
Defective Device
 32
Calibration Problem
 32
Misconnection
 31
Device Reprocessing Problem
 31
Positioning Problem
 30
Device Damaged By Another Device
 29
Device Operational Issue
 29
Manufacturing, Packaging Or Shipping Problem
 27
Thread
 26
Material Separation
 25
Peeled / Delaminated
 24
Device Damaged Prior To Use
24
Failure To Disconnect
 23
Difficult To Position
 23
Driver
 22
No Apparent Adverse Event
 22
Shaft
 21
Failure To Advance
 21
Unintended Movement
 20
Residue After Decontamination
 18
Difficult To Open Or Close
 18
Contamination / Decontamination Problem
17
Migration Or Expulsion Of Device
17
Device Or Device Fragments Location Unknown
 17
Device Markings / Labelling Problem
 17
Packaging Problem
 16
Improper Or Incorrect Procedure Or Method
 16
Defective Component
 15
Device Handling Problem
 15
Separation Problem
14
Misassembled
 14
Split
 13
Component Falling
 13
Material Distortion
 12
Deformation Due To Compressive Stress
12
Activation, Positioning Or Separation Problem
 11
Material Split, Cut Or Torn
 11
Incorrect Measurement
 11
Pin
 11
Mechanics Altered
 11
Entrapment Of Device
 11
Nonstandard Device
 11
Rod
 10
Problem With Sterilization
 10
Illegible Information
 10
Loss Of Or Failure To Bond
 10
Delivered As Unsterile Product
 10
Device Difficult To Maintain
 9
Device Disinfection Or Sterilization Issue
 9
Knife
 9
Malposition Of Device
8
Disconnection
 8
Positioning Failure
8
Inadequacy Of Device Shape And/or Size
 8
Output Above Specifications
 8
Total Device Problems 20582
Recalls
Manufacturer Recall Class Date Posted
1
Acumed LLC
 II Mar-16-2017
2
Ad-Tech Medical Instrument Corporation
 II May-25-2018
3
Amendia, Inc
 II Apr-25-2017
4
Amendia, Inc
 II Dec-22-2016
5
ArthroCare Medical Corporation
 II Jan-09-2014
6
Bacterin International, Inc.
 II Apr-07-2015
7
Biomet U.K., Ltd.
 II Feb-22-2017
8
Biomet, Inc.
 II May-26-2016
9
Biomet, Inc.
 II Feb-25-2016
10
Biomet, Inc.
 II Jun-16-2014
11
Biomet, Inc.
 II Mar-20-2014
12
Captiva Spine, Inc
 II Apr-21-2015
13
Cardinal Health 200, LLC
 II Oct-11-2016
14
DePuy Mitek, Inc., A Johnson & Johnson Co.
 II Oct-23-2018
15
DePuy Mitek, Inc., A Johnson & Johnson Co.
 II May-08-2018
16
DePuy Orthopaedics, Inc.
 II Mar-02-2018
17
DePuy Orthopaedics, Inc.
 II Jun-08-2017
18
DePuy Orthopaedics, Inc.
 II Oct-07-2015
19
DePuy Orthopaedics, Inc.
 II Mar-31-2015
20
DePuy Orthopaedics, Inc.
 II Jan-12-2015
21
DePuy Orthopaedics, Inc.
 II Jan-05-2015
22
DePuy Orthopaedics, Inc.
 II Jan-05-2015
23
DePuy Orthopaedics, Inc.
 II Nov-10-2014
24
DePuy Orthopaedics, Inc.
 II Oct-08-2014
25
Exactech, Inc.
 II Oct-11-2018
26
Exactech, Inc.
 II Jun-19-2017
27
Exactech, Inc.
 II Jun-19-2017
28
Flower Orthopedics Corporation
 II Jan-28-2017
29
Greatbatch Medical
 II Feb-11-2017
30
Howmedica Osteonics Corp.
 II Dec-21-2018
31
Howmedica Osteonics Corp.
 II Nov-02-2018
32
Howmedica Osteonics Corp.
 II Oct-23-2018
33
Howmedica Osteonics Corp.
 II Mar-01-2018
34
Implant Direct Sybron Manufacturing, LLC
 II Sep-11-2017
35
LDR Spine USA, Inc.
 II Oct-05-2016
36
Limacorporate S.p.A
 II Nov-06-2017
37
Limacorporate S.p.A
 II Aug-31-2016
38
MEDLINE INDUSTRIES INC
 II May-17-2017
39
Medtronic Sofamor Danek USA Inc
 II May-05-2017
40
Microport Orthopedics INC.
 II Jun-04-2014
41
OMNIlife Science Inc.
 II Feb-14-2019
42
Orthohelix Surgical Designs Inc
 II Oct-10-2014
43
Robert Busse & Co. Inc. D.b.a. Busse Hospital Disposables
 II Dec-22-2016
44
Smith & Nephew, Inc.
 II Jan-12-2019
45
SpineFrontier, Inc.
 II Jan-14-2015
46
Stryker Howmedica Osteonics Corp.
 II Jan-12-2017
47
Stryker Howmedica Osteonics Corp.
 II Jul-02-2014
48
Stryker Howmedica Osteonics Corp.
 II Feb-10-2014
49
Stryker Instruments Div. Of Stryker Corporation
 II Mar-28-2018
50
Stryker Spine
 II Feb-19-2016
51
Stryker Spine
 II Nov-05-2015
52
Stryker Spine
 II Dec-16-2014
53
Stryker Spine
 II Sep-11-2014
54
Stryker Spine
 II Feb-25-2014
55
Synthes (USA) Products LLC
 II Feb-27-2017
56
Synthes (USA) Products LLC
 II Nov-19-2016
57
Synthes (USA) Products LLC
 II Oct-15-2015
58
Synthes (USA) Products LLC
 II Oct-05-2015
59
Synthes, Inc.
 II Apr-24-2018
60
Synthes, Inc.
 II Mar-10-2015
61
Synthes, Inc.
 II Jul-21-2014
62
Synthes, Inc.
 II Feb-20-2014
63
Synthes, Inc.
 II Feb-16-2014
64
Thayer Intellectual Property, Inc.
 II Dec-03-2016
65
TriMed Inc.
 II Apr-12-2018
66
United Orthopedic Corporation
 II Mar-01-2017
67
Vertebral Technologies, Inc.
 II Feb-08-2017
68
Zimmer Biomet, Inc.
 II Nov-30-2018
69
Zimmer Biomet, Inc.
 II Aug-18-2018
70
Zimmer Biomet, Inc.
 II Aug-17-2018
71
Zimmer Biomet, Inc.
 II Apr-20-2018
72
Zimmer Biomet, Inc.
 II Mar-28-2018
73
Zimmer Biomet, Inc.
 II Mar-06-2018
74
Zimmer Biomet, Inc.
 II Feb-27-2018
75
Zimmer Biomet, Inc.
 II Feb-07-2018
76
Zimmer Biomet, Inc.
 II Feb-04-2018
77
Zimmer Biomet, Inc.
 II Apr-25-2017
78
Zimmer Biomet, Inc.
 II Oct-14-2016
79
Zimmer Gmbh
 II Aug-02-2016
80
Zimmer Gmbh
 II Apr-27-2015
81
Zimmer, Inc.
 II Dec-10-2015
82
Zimmer, Inc.
 II May-29-2015
83
Zimmer, Inc.
 II Aug-26-2014
84
Zimmer, Inc.
 II Aug-22-2014
85
Zimmer, Inc.
 II Aug-14-2014
TPLC Last Update: 2019-04-02 20:52:37
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