| Device Type ID | 5586 |
| Device Name | Retractor |
| Regulation Description | Manual Surgical Instrument For General Use. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GAD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5586 |
| Device | Retractor |
| Product Code | GAD |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SPINEART | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 91 |
Material Deformation | 18 |
Fracture | 18 |
Adverse Event Without Identified Device Or Use Problem | 17 |
Detachment Of Device Or Device Component | 15 |
Detachment Of Device Component | 14 |
Device Operates Differently Than Expected | 13 |
Material Fragmentation | 10 |
Crack | 8 |
Disassembly | 8 |
Appropriate Term/Code Not Available | 7 |
Difficult To Remove | 6 |
Device-Device Incompatibility | 5 |
Fitting Problem | 4 |
Component Missing | 4 |
Difficult To Open Or Close | 3 |
Device Dislodged Or Dislocated | 3 |
Difficult Or Delayed Positioning | 3 |
Connection Problem | 3 |
Bent | 3 |
Failure To Adhere Or Bond | 3 |
Product Quality Problem | 3 |
Unintended Movement | 3 |
Device Slipped | 3 |
Positioning Problem | 3 |
Scratched Material | 2 |
Insufficient Information | 2 |
Overheating Of Device | 2 |
Mechanical Jam | 2 |
Material Twisted / Bent | 2 |
Use Of Device Problem | 2 |
Screw | 1 |
Device Difficult To Setup Or Prepare | 1 |
Retraction Problem | 1 |
Device Reprocessing Problem | 1 |
Migration Or Expulsion Of Device | 1 |
Device Inoperable | 1 |
Material Integrity Problem | 1 |
Corroded | 1 |
Device Handling Problem | 1 |
Component Or Accessory Incompatibility | 1 |
Sticking | 1 |
Missing Value Reason | 1 |
Packaging Problem | 1 |
Knife | 1 |
Failure To Align | 1 |
Defective Device | 1 |
Mechanical Problem | 1 |
Flaked | 1 |
Dull, Blunt | 1 |
Malfunction | 1 |
Malposition Of Device | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Material Distortion | 1 |
| Total Device Problems | 303 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Aesculap, Inc. | II | Dec-31-2015 |
| 2 | Applied Medical Technology Inc | II | May-05-2016 |
| 3 | Biomet, Inc. | II | Mar-10-2016 |
| 4 | CooperSurgical, Inc. | II | Sep-27-2018 |
| 5 | Synthes (USA) Products LLC | II | May-09-2018 |
| 6 | Synthes (USA) Products LLC | II | Aug-19-2015 |
| 7 | Synthes, Inc. | II | Jan-14-2015 |
| 8 | Synthes, Inc. | II | Oct-20-2014 |
| 9 | Synthes, Inc. | II | Apr-15-2014 |