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 |
|---|---|---|---|---|
| 3033273526 | Artelon | ATL, GA, US | — | |
| 3006125657 | BERCHTOLD GMBH & CO. KG | TUTTLINGEN Baden-Wurttemberg, DE | — | |
| 3003897776 | BIOMIMETIC THERAPEUTICS,LLC | FRANKLIN, TN, US | VAI | |
| 3006345872 | Entellus Medical, Inc | Plymouth, MN, US | OAI | |
| 3004123209 | HEARTSINE TECHNOLOGIES, LTD | BELFAST Northern Ireland, GB | NAI | |
| 3002807172 | HOWMEDICA INTERNATIONAL S. DE R.L., | LIMERICK Munster, IE | NAI | |
| 3003070421 | HOWMEDICA OSTEONICS CORP | MAHWAH, NJ, US | VAI | |
| 3005920920 | HYPERBRANCH MEDICAL TECHNOLOGY INC | Durham, NC, US | NAI | |
| 3014027736 | IMASCAP | PLOUZANE Finistere, FR | — | |
| 3010673515 | INTERNATIONAL LIFE SCIENCES | Sandy Springs, GA, US | NAI | |
| 3040801290 | Inari Medical, Costa Rica S.A. | Grecia Alajuela, CR | — | |
| 3020347218 | Inari Medical, Inc. | Irvine, CA, US | — | |
| 3005445717 | JOLIFE AB | LUND Skane, SE | NAI | |
| 3023527320 | LimFlow Inc. | Irvine, CA, US | VAI | |
| 3005985723 | MAKO SURGICAL CORP. | Weston, FL, US | VAI | |
| 3010151377 | MOBIUS IMAGING, LLC | Shirley, MA, US | VAI | |
| 3007456622 | NICO CORPORATION | Indianapolis, IN, US | VAI | |
| 3012345110 | Novadaq Technologies ULC | Burnaby British Columbia, CA | VAI | |
| 3016573902 | Ortho-Space Ltd. | Caesarea Haifa, IL | — | |
| 3015876 | PHYSIO-CONTROL, INC. | Redmond, WA, US | NAI | |
| 3010411911 | POM Medical, LLC | Moorpark, CA, US | NAI | |
| 3008668801 | SERF | DECINES CHARPIEU Rhone, FR | NAI | |
| 3002975342 | STRYKER Communications, Inc. | Flower Mound, TX, US | NAI | |
| 1811755 | STRYKER CORP. | KALAMAZOO, MI, US | NAI | |
| 3008837339 | STRYKER EMEA Supply Chain Services | Venlo Limburg, NL | — |
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