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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


Premarket Reviews
ManufacturerDecision
ORTHOVITA
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 9166
Fracture 1736
Appropriate Term/Code Not Available 1643
Crack 1165
Device-Device Incompatibility 603
Naturally Worn 560
Mechanical Jam 510
Device Operates Differently Than Expected 494
Material Integrity Problem 488
Dull, Blunt 475
Scratched Material 437
Material Deformation 429
Mechanical Problem 382
Bent 381
Material Twisted / Bent 373
Corroded 340
Material Fragmentation 328
Component Missing 328
Insufficient Information 308
Fitting Problem 199
Adverse Event Without Identified Device or Use Problem 188
Tip 184
Failure to Align 174
Difficult to Remove 163
Detachment Of Device Component 161
Detachment of Device or device Component 144
Disassembly 126
Loose or Intermittent Connection 121
Material Discolored 120
Connection Problem 108
Device Contamination with Chemical or Other Material 108
Physical Resistance / Sticking 85
Screw 82
Sticking 71
Calibration Problem 70
Separation Failure 65
Degraded 62
Failure To Adhere Or Bond 61
Use of Device Problem 56
Difficult to Insert 53
Metal Shedding Debris 46
Unintended Movement 46
Peeled / Delaminated 44
Device Dislodged or Dislocated 40
Device Slipped 39
Device Issue 38
Handpiece 38
Device Inoperable 36
Device Damaged Prior to Use 35
Positioning Problem 34
Material Separation 33
Device Reprocessing Problem 32
Defective Device 32
Device Damaged by Another Device 32
Misconnection 31
Device Operational Issue 29
Device Markings / Labelling Problem 29
Manufacturing, Packaging or Shipping Problem 28
Contamination / decontamination Problem 28
No Apparent Adverse Event 28
Thread 26
Failure to Disconnect 26
Difficult to Open or Close 26
Difficult To Position 23
Driver 22
Shaft 21
Positioning Failure 21
Display Difficult to Read 21
Failure to Advance 21
Device Difficult to Maintain 21
Entrapment of Device 20
Material Disintegration 19
Migration or Expulsion of Device 18
Defective Component 18
Improper or Incorrect Procedure or Method 18
Residue After Decontamination 18
Device Or Device Fragments Location Unknown 17
Delivered as Unsterile Product 17
Packaging Problem 16
Device Handling Problem 16
Deformation Due to Compressive Stress 15
Separation Problem 14
Misassembled 14
Component Falling 13
Split 13
Material Distortion 12
Failure to Clean Adequately 12
Illegible Information 12
Material Split, Cut or Torn 12
Incorrect Measurement 12
Problem with Sterilization 12
Nonstandard device 11
Pin 11
Patient Device Interaction Problem 11
Mechanics Altered 11
Compatibility Problem 11
Activation, Positioning or Separation Problem 11
Rod 10
Disconnection 10
Loss of or Failure to Bond 10
Total Device Problems 23887

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 Apr-11-2019
17 DePuy Orthopaedics, Inc. II Mar-02-2018
18 DePuy Orthopaedics, Inc. II Jun-08-2017
19 DePuy Orthopaedics, Inc. II Oct-07-2015
20 DePuy Orthopaedics, Inc. II Mar-31-2015
21 DePuy Orthopaedics, Inc. II Jan-12-2015
22 DePuy Orthopaedics, Inc. II Jan-05-2015
23 DePuy Orthopaedics, Inc. II Jan-05-2015
24 DePuy Orthopaedics, Inc. II Nov-10-2014
25 DePuy Orthopaedics, Inc. II Oct-08-2014
26 Exactech, Inc. II Oct-11-2018
27 Exactech, Inc. II Jun-19-2017
28 Exactech, Inc. II Jun-19-2017
29 Flower Orthopedics Corporation II Jan-28-2017
30 Greatbatch Medical II Feb-11-2017
31 Howmedica Osteonics Corp. II Dec-21-2018
32 Howmedica Osteonics Corp. II Nov-02-2018
33 Howmedica Osteonics Corp. II Oct-23-2018
34 Howmedica Osteonics Corp. II Mar-01-2018
35 Implant Direct Sybron Manufacturing, LLC II Sep-11-2017
36 LDR Spine USA, Inc. II Oct-05-2016
37 Limacorporate S.p.A II Nov-06-2017
38 Limacorporate S.p.A II Aug-31-2016
39 MEDLINE INDUSTRIES INC II May-17-2017
40 Medtronic Sofamor Danek USA Inc II May-05-2017
41 Microport Orthopedics INC. II Jun-04-2014
42 OMNIlife science Inc. II Feb-14-2019
43 Orthohelix Surgical Designs Inc II Oct-10-2014
44 Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables II Dec-22-2016
45 Smith & Nephew, Inc. II Jan-12-2019
46 SpineFrontier, Inc. II Jan-14-2015
47 Stryker Howmedica Osteonics Corp. II Jan-12-2017
48 Stryker Howmedica Osteonics Corp. II Jul-02-2014
49 Stryker Howmedica Osteonics Corp. II Feb-10-2014
50 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
51 Stryker Spine II Feb-19-2016
52 Stryker Spine II Nov-05-2015
53 Stryker Spine II Dec-16-2014
54 Stryker Spine II Sep-11-2014
55 Stryker Spine II Feb-25-2014
56 Synthes (USA) Products LLC II Feb-27-2017
57 Synthes (USA) Products LLC II Nov-19-2016
58 Synthes (USA) Products LLC II Oct-15-2015
59 Synthes (USA) Products LLC II Oct-05-2015
60 Synthes, Inc. II Apr-24-2018
61 Synthes, Inc. II Mar-10-2015
62 Synthes, Inc. II Jul-21-2014
63 Synthes, Inc. II Feb-20-2014
64 Synthes, Inc. II Feb-16-2014
65 Thayer Intellectual Property, Inc. II Dec-03-2016
66 TriMed Inc. II Apr-12-2018
67 United Orthopedic Corporation II Mar-01-2017
68 Vertebral Technologies, Inc. II Feb-08-2017
69 Zimmer Biomet, Inc. II Jul-04-2019
70 Zimmer Biomet, Inc. II Jun-19-2019
71 Zimmer Biomet, Inc. II Jun-06-2019
72 Zimmer Biomet, Inc. II Nov-30-2018
73 Zimmer Biomet, Inc. II Aug-18-2018
74 Zimmer Biomet, Inc. II Aug-17-2018
75 Zimmer Biomet, Inc. II Apr-20-2018
76 Zimmer Biomet, Inc. II Mar-28-2018
77 Zimmer Biomet, Inc. II Mar-06-2018
78 Zimmer Biomet, Inc. II Feb-27-2018
79 Zimmer Biomet, Inc. II Feb-07-2018
80 Zimmer Biomet, Inc. II Feb-04-2018
81 Zimmer Biomet, Inc. II Apr-25-2017
82 Zimmer Biomet, Inc. II Oct-14-2016
83 Zimmer Gmbh II Aug-02-2016
84 Zimmer Gmbh II Apr-27-2015
85 Zimmer, Inc. II Dec-10-2015
86 Zimmer, Inc. II May-29-2015
87 Zimmer, Inc. II Aug-26-2014
88 Zimmer, Inc. II Aug-22-2014
89 Zimmer, Inc. II Aug-14-2014

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