Scorecard
Events per device across the 105-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0.010 →
1 in the last 12 months
Higher volume than 87% of companies with 10+ devices
Recalls per device
0 →
0 in the last 12 months
Higher volume than 97% of companies with 10+ devices
These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.
Devices
105 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|
| Orthopedic Cannulated Nail Instrument Pack | 964-003 | LXH | 00857676008669 | 0 |
| Orthopedic Cannulated Nail Instrument Pack 3.0 x 50mm | 964-001 | LXH | 00857676008577 | 0 |
| Orthopedic Cannulated Nail Instrument Pack 4.0 x 100mm | 964-002 | LXH | 00857676008584 | 0 |
| PFT Adapter, SYK, Mariner, 105 in-lb (228-TXRX-007) | 228-TXRX-007 | HWE | 00850078396310 | 0 |
| PFT Adapter, SYK, Virata, 85 in-lb (228-TXRX-006) | 228-TXRX-006 | HWE | 00850078396303 | 0 |
| Palm Handle, 2 mm Hex Torque Limiting Instrument | 218-035 | LXH | 00857676008591 | 0 |
| Revcon Instrument Kit, Sterile | 4.0MM | LXH | 00857676008676 | 0 |
| Revcon Instrument Kit, Sterile | 3.0MM | LXH | 00857676008683 | 0 |
| Rotation Arc Accessory Pack | 975-003 | LXH | 00850078396099 | 0 |
| Shannon Bur, Sterile | 2.0MM x 16 MM | LXH | 00857676008690 | 0 |
| Sizing Template Accessory Pa | 1016 | LXH | 00857676008829 | 0 |
| Stryker | 220-TXTS-006 | LXH | 00857676008232 | 0 |
| T8 Driver Accessory Pack | 1005 | LXH | 00857676008775 | 0 |
| TRAQ Single Use Instrument Kit | 1042 | LXH | 00850078396280 | 0 |
| TRUPWR TORQUE LIMITING ATTACHMENT STERILE, SINGLE USE | | | | 0 |
| TRUTORQ ADAPTOR STERILE, SINGLE USE | | | | 0 |
| Threaded Trimmable Fixation Nail Beveled Instrument Pack | 967-005 | LXH | 00850078396068 | 0 |
| Threaded Trimmable Fixation Nail F/A Instrument Pack | F/A Pack | LXH | 00857676008614 | 0 |
| Threaded Trimmable Fixation Nail H/W Instrument Pack | H/W Pack | LXH | 00857676008607 | 0 |
| Threaded Trimmable Fixation Nail Instrument Pack 5.5 | 5.5 Instrument Pack | LXH | 00857676008638 | 0 |
| Threaded Trimmable Fixation Nail Sizing Guide Pack | Sizing guide pack | LXH | 00857676008621 | 0 |
| TransLoc 3D SI Fusion Screw Instruments™ | 1014 | LXH | 00850078396051 | 0 |
| TransLoc 3D, 18” Wire and Measurement Guide | 1015 | LXH | 00850078396112 | 0 |
| TransLoc 3D, Depth Gauge for All-Metal Introducer | 1030 | LXH | 00850078396129 | 0 |
| TruAim Lapidus System Sterile, Single Use | A | LXH | 00857676008324 | 0 |
| TruAim Lisfranc System Sterile, Single Use | A | LXH | 00857676008263 | 0 |
| TruFIX | Fixed Driver AO, Small Axial | LXH | 00857676008218 | 0 |
| TruFIX | Fixed Driver AO, Small Axial | LXH | 00857676008201 | 0 |
| TruPWR Torque Limiting Attachment Sterile, Single Use 11.3Nm | 228-TXRX-005 | HWE | 00850078396082 | 0 |
| TruPWR Torque Limiting Attachment, 12 Nm | 12 Nm | | 00857676008348 | 0 |
Showing 61–90 of 105← PrevNext → Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|
| 3010052483 | ECA MEDICAL INSTRUMENTS | Newbury Park, CA, US | VAI | |