Stryker Corporation
12690 adverse events · 1783 recalls · 273 clearances · 141 inspections · 5 compliance actions · aggregated across 6 source records
Scorecard
Events per device across the 36,412-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0.048 ▼
1,750 in the last 12 months
Higher volume than 91% of companies with 10+ devices
Recalls per device
0.002 ▼
63 in the last 12 months
Higher volume than 98% 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
36,412 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| Connected OR Hub | 0240200100 | GCJ HRX | 07613327413281 | 116 |
| (unnamed) | 5051 | FPO | 07613327278361 | 116 |
| (unnamed) | 5407-120-950C | HBE | 07613327096491 | 116 |
| CinchLock | CAT02462 | MBI | 07613252633228 | 115 |
| (unnamed) | 5450040002 | ERL | 07613252508090 | 115 |
| Gynnie | 1061 | FPO | 07613327278200 | 114 |
| STRYKER | 7400-031-000 | ERL | 07613327482973 | 112 |
| Maestro | 5400210058 | ERL | 04546540469205 | 110 |
| (unnamed) | 8208000000 | HWE | 07613327304541 | 110 |
| (unnamed) | 8205000000 | HWE OLO | 07613327304466 | 110 |
| Power-LOAD | 6390 | FPO | 07613327261523 | 110 |
| ProCuity | 300900000000 | FNL | 07613327512656 | 110 |
| S3 | 3005 | FNL | 07613327278422 | 110 |
| (unnamed) | 5407-120-470 | HBE | 07613327096569 | 107 |
| Prime Series | 1105 | FPO | 07613327278156 | 105 |
| Power-PRO 2, High Configuration | 650705550001 | FPO | 07613327559118 | 104 |
| Maestro Air | 5407-200-000 | HBB | 07613327096460 | 103 |
| Synchro SELECT | SSFT215STR | DQX MOF | 07613327508574 | 103 |
| Formula | 0375544000 | GFA | 07613327061789 | 101 |
| L9000 | 0220210000 | FCW | 07613327051339 | 101 |
| (unnamed) | 0277096325 | GFA | 04546540051783 | 101 |
| GAMMA | 1320-0111 | HSB | 04546540716774 | 100 |
| (unnamed) | 5407-120-050 | HBE | 07613327096651 | 100 |
| Prime TC | 1460-000-000 | INN | 07613327282665 | 100 |
| Synchro SELECT | SSTD215STR | DQX MOF | 07613327508499 | 100 |
| RemB | 6400099000 | ERL | 07613154938353 | 99 |
| Neptune | 0703047002 | GEI | 07613327379471 | 98 |
| (unnamed) | 8206000000 | HWE | 07613327304473 | 97 |
| CrossFlow | 0450000000 | HRX | 07613327058048 | 96 |
| (unnamed) | 7206000000 | HWE | 07613327064834 | 94 |
Compliance actions
FDA warning letters and enforcement actions (full history).
| Date | Type | Action | Firm |
|---|---|---|---|
| 2017-04-06 | WL | Warning Letter | Entellus Medical Inc. |
| 2015-04-08 | WL | Warning Letter | Thermedx LLC |
| 2013-11-26 | INJ | Injunction | Physio-Control, Inc. |
| 2013-03-06 | WL | Warning Letter | Stryker Corporation |
| 2013-03-06 | WL | Warning Letter | Stryker Corporation |
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|---|---|---|---|
| 3020163307 | Stryker Tijuana Operations | Tijuana Baja California, MX | — | |
| 3012497308 | Stryker US Supply Chain Operations | Plainfield, IN, US | — | |
| 3007495879 | THERMEDX, LLC | Solon, OH, US | VAI | |
| 3001237463 | TMJ Solutions, LLC | San Buenaventura, CA, US | NAI | |
| 3004983210 | TORNIER Inc. | Columbia City, IN, US | NAI | |
| 3008388276 | TORNIER S.A.S | Montbonnot Saint-Martin Isere, FR | — | |
| 3000718467 | TORNIER, INC. | Bloomington, MN, US | NAI | |
| 3003902387 | TORNIER, SAS | GRENOBLE CEDEX 1 Isere, FR | — | |
| 3000931034 | Tornier S.A.S. | Montbonnot Saint-Martin Isere, FR | VAI | |
| 1043534 | WRIGHT MEDICAL TECHNOLOGY, INC. | Arlington, TN, US | VAI | |
| 3010667733 | WRIGHT MEDICAL TECHNOLOGY, INC. | Arlington, TN, US | VAI |
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