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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orthopedic manual surgical instrument
Regulation Description Orthopedic manual surgical instrument.
Product CodeLXH
Regulation Number 888.4540
Device Class 1

Device Problems
Break 9928
Fracture 1883
Appropriate Term/Code Not Available 1655
Crack 1233
Device-Device Incompatibility 1032
Material Twisted / Bent 755
Scratched Material 687
Naturally Worn 599
Mechanical Jam 587
Material Deformation 537
Device Operates Differently Than Expected 475
Dull, Blunt 472
Mechanical Problem 442
Material Integrity Problem 424
Corroded 407
Bent 371
Material Fragmentation 368
Component Missing 368
Insufficient Information 302
Adverse Event Without Identified Device or Use Problem 225
Fitting Problem 207
Failure to Align 185
Detachment of Device or device Component 182
Difficult to Remove 175
Calibration Problem 154
Tip 137
Material Discolored 132
Loose or Intermittent Connection 131
Detachment Of Device Component 130
Disassembly 122
Illegible Information 122
Connection Problem 119
Physical Resistance / Sticking 116
Device Contamination with Chemical or Other Material 112
Separation Failure 67
Failure To Adhere Or Bond 61
Sticking 61
Screw 59
Unintended Movement 58
Use of Device Problem 56
Difficult to Insert 56
Contamination / decontamination Problem 53
Material Separation 50
Device Slipped 48
Metal Shedding Debris 45
Peeled / Delaminated 42
Device Dislodged or Dislocated 39
Positioning Problem 39
Device Issue 38
Device Damaged by Another Device 37
Device Damaged Prior to Use 37
Positioning Failure 34
Defective Device 34
Device Reprocessing Problem 32
Misconnection 31
Difficult to Open or Close 31
Failure to Advance 30
Degraded 30
Material Disintegration 29
Device Operational Issue 29
Device Markings / Labelling Problem 29
Entrapment of Device 27
Manufacturing, Packaging or Shipping Problem 26
Failure to Disconnect 26
Handpiece 26
No Apparent Adverse Event 26
Difficult To Position 23
Display Difficult to Read 22
Device Difficult to Maintain 21
Residue After Decontamination 21
Thread 20
Defective Component 20
Device Inoperable 19
Migration or Expulsion of Device 18
Device Handling Problem 18
Failure to Cut 18
Compatibility Problem 17
Packaging Problem 17
Mechanics Altered 16
Device Or Device Fragments Location Unknown 16
Shaft 16
Improper or Incorrect Procedure or Method 15
Deformation Due to Compressive Stress 15
Separation Problem 14
Problem with Sterilization 14
Incorrect Measurement 14
Driver 14
Delivered as Unsterile Product 13
Material Split, Cut or Torn 13
Split 13
Material Distortion 12
Failure to Clean Adequately 12
Misassembled 12
Difficult or Delayed Positioning 12
Component Falling 11
Nonstandard device 11
Patient Device Interaction Problem 11
Activation, Positioning or Separation Problem 11
Malposition of device 10
Device Difficult to Setup or Prepare 10
Total Device Problems 26579

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 Arthrex, Inc. II Jan-30-2020
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 Captiva Spine, Inc II Apr-21-2015
11 Cardinal Health 200, LLC II Oct-11-2016
12 DePuy Mitek, Inc., a Johnson & Johnson Co. II Oct-23-2018
13 DePuy Mitek, Inc., a Johnson & Johnson Co. II May-08-2018
14 DePuy Orthopaedics, Inc. II Apr-11-2019
15 DePuy Orthopaedics, Inc. II Mar-02-2018
16 DePuy Orthopaedics, Inc. II Jun-08-2017
17 DePuy Orthopaedics, Inc. II Oct-07-2015
18 DePuy Orthopaedics, Inc. II Mar-31-2015
19 DePuy Orthopaedics, Inc. II Jan-12-2015
20 DePuy Orthopaedics, Inc. II Jan-05-2015
21 DePuy Orthopaedics, Inc. II Jan-05-2015
22 Encore Medical, Lp II Dec-06-2019
23 Exactech, Inc. II Oct-11-2018
24 Exactech, Inc. II Jun-19-2017
25 Exactech, Inc. II Jun-19-2017
26 Flower Orthopedics Corporation II Jan-28-2017
27 Greatbatch Medical II Feb-11-2017
28 Howmedica Osteonics Corp. II Dec-21-2018
29 Howmedica Osteonics Corp. II Nov-02-2018
30 Howmedica Osteonics Corp. II Oct-23-2018
31 Howmedica Osteonics Corp. II Mar-01-2018
32 Implant Direct Sybron Manufacturing, LLC II Sep-11-2017
33 LDR Spine USA, Inc. II Oct-05-2016
34 Limacorporate S.p.A II Nov-06-2017
35 Limacorporate S.p.A II Aug-31-2016
36 MEDLINE INDUSTRIES INC II May-17-2017
37 Medtronic Sofamor Danek USA Inc II May-05-2017
38 OMNIlife science Inc. II Feb-14-2019
39 Pega Medical Inc. III May-15-2020
40 Pega Medical Inc. II Nov-01-2019
41 Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables II Dec-22-2016
42 Smith & Nephew, Inc. II Nov-08-2019
43 Smith & Nephew, Inc. II Jan-12-2019
44 SpineFrontier, Inc. II Jan-14-2015
45 Stryker Howmedica Osteonics Corp. II Jan-12-2017
46 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
47 Stryker Spine II Feb-19-2016
48 Stryker Spine II Nov-05-2015
49 Synthes (USA) Products LLC II Feb-27-2017
50 Synthes (USA) Products LLC II Nov-19-2016
51 Synthes (USA) Products LLC II Oct-15-2015
52 Synthes (USA) Products LLC II Oct-05-2015
53 Synthes, Inc. II Apr-24-2018
54 Synthes, Inc. II Mar-10-2015
55 TeDan Surgical Innovations LLC II Mar-17-2020
56 Thayer Intellectual Property, Inc. II Dec-03-2016
57 TriMed Inc. II Nov-12-2019
58 TriMed Inc. II Apr-12-2018
59 United Orthopedic Corporation II Mar-01-2017
60 Vertebral Technologies, Inc. II Feb-08-2017
61 Zimmer Biomet, Inc. II Jun-02-2020
62 Zimmer Biomet, Inc. II Jan-28-2020
63 Zimmer Biomet, Inc. II Dec-03-2019
64 Zimmer Biomet, Inc. II Nov-22-2019
65 Zimmer Biomet, Inc. II Nov-07-2019
66 Zimmer Biomet, Inc. II Jul-04-2019
67 Zimmer Biomet, Inc. II Jun-19-2019
68 Zimmer Biomet, Inc. II Jun-06-2019
69 Zimmer Biomet, Inc. II Nov-30-2018
70 Zimmer Biomet, Inc. II Aug-18-2018
71 Zimmer Biomet, Inc. II Aug-17-2018
72 Zimmer Biomet, Inc. II Apr-20-2018
73 Zimmer Biomet, Inc. II Mar-28-2018
74 Zimmer Biomet, Inc. II Mar-06-2018
75 Zimmer Biomet, Inc. II Feb-27-2018
76 Zimmer Biomet, Inc. II Feb-07-2018
77 Zimmer Biomet, Inc. II Feb-04-2018
78 Zimmer Biomet, Inc. II Apr-25-2017
79 Zimmer Biomet, Inc. II Oct-14-2016
80 Zimmer Gmbh II Aug-02-2016
81 Zimmer Gmbh II Apr-27-2015
82 Zimmer, Inc. II Dec-10-2015
83 Zimmer, Inc. II May-29-2015

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