| Device Type ID | 5511 |
| Device Name | Tray, Surgical, Instrument |
| 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) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FSM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5511 |
| Device | Tray, Surgical, Instrument |
| Product Code | FSM |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Delamination | 98 |
Break | 55 |
Peeled / Delaminated | 33 |
Appropriate Term/Code Not Available | 24 |
Adverse Event Without Identified Device Or Use Problem | 21 |
Material Fragmentation | 7 |
Flaked | 6 |
Failure To Align | 5 |
Device Operates Differently Than Expected | 4 |
Residue After Decontamination | 3 |
Defective Device | 3 |
Detachment Of Device Or Device Component | 3 |
Device Damaged Prior To Use | 3 |
Manufacturing, Packaging Or Shipping Problem | 3 |
Loose Or Intermittent Connection | 2 |
Device Markings / Labelling Problem | 2 |
Crack | 2 |
Component Incompatible | 2 |
Coagulation In Device Or Device Ingredient | 2 |
Component Missing | 2 |
Physical Property Issue | 2 |
Loss Of Or Failure To Bond | 2 |
Corroded | 2 |
Failure To Adhere Or Bond | 1 |
Bent | 1 |
Device Reprocessing Problem | 1 |
Migration Or Expulsion Of Device | 1 |
Incorrect Measurement | 1 |
Metal Shedding Debris | 1 |
Tip | 1 |
Delivered As Unsterile Product | 1 |
Electromagnetic Interference | 1 |
Material Separation | 1 |
Device Issue | 1 |
Component Or Accessory Incompatibility | 1 |
Device Packaging Compromised | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Sticking | 1 |
Fitting Problem | 1 |
Incorrect Device Or Component Shipped | 1 |
Detachment Of Device Component | 1 |
Overheating Of Device | 1 |
Incorrect Or Inadequate Test Results | 1 |
Insufficient Information | 1 |
Difficult To Advance | 1 |
Material Erosion | 1 |
Difficult Or Delayed Activation | 1 |
Positioning Problem | 1 |
Scratched Material | 1 |
Sharp Edges | 1 |
| Total Device Problems | 313 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Robert Busse & Co. Inc. D.b.a. Busse Hospital Disposables | II | Dec-22-2016 |
| 2 | Stryker Craniomaxillofacial Division | II | Oct-08-2015 |
| 3 | Synthes (USA) Products LLC | II | Jun-15-2018 |
| 4 | Synthes (USA) Products LLC | II | Dec-21-2016 |
| 5 | Synthes (USA) Products LLC | II | Aug-20-2015 |
| 6 | Zimmer Biomet, Inc. | II | Jan-14-2019 |
| 7 | Zimmer, Inc. | II | Oct-06-2015 |
| 8 | Zimmer, Inc. | II | Aug-20-2014 |