Stryker GmbH
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 |
|---|---|---|---|---|
| (unnamed) | 7206000000 | HWE | 07613327064834 | 94 |
| (unnamed) | 5407-120-452 | HBE | 07613327096552 | 93 |
| S3 | 3005 | FNL | 07613327278378 | 91 |
| Maestro | 5400210060 | HBB | 04546540469229 | 90 |
| (unnamed) | 5407-120-480 | HBE | 07613327096583 | 90 |
| (unnamed) | 5050 | FPO | 07613327282511 | 90 |
| (unnamed) | 4505000000 | HWE | 07613327304459 | 90 |
| (unnamed) | 7208000000 | HWE | 07613252251033 | 89 |
| FlowGate2 | 90495 | DQY | 00815742004953 | 87 |
| InTouch | 2131 | FNL | 07613327169294 | 87 |
| REUNION | 5572-4516 | KWS | 07613327098716 | 87 |
| (unnamed) | 5407521008 | ERL | 07613252503835 | 85 |
| (unnamed) | 5407-FA3-000 | HBE | 07613327096477 | 83 |
| Power PRO | 6506 | FPO | 07613327513271 | 83 |
| SDC3 | 0240060100 | GCJ HRX | 07613327056150 | 83 |
| Maestro | 5400210050 | ERL | 04546540469175 | 82 |
| (unnamed) | 4100125000 | HWE | 04546540068163 | 82 |
| Surgistool | 0830 | FZM | 07613327282566 | 81 |
| L10 | 0220220300 | OWN | 07613327051377 | 80 |
| (unnamed) | 0747 | FPO | 07613327278187 | 80 |
| (unnamed) | 8203126000 | HWE | 07613327304558 | 79 |
| (unnamed) | 5407-NFA-8CM | HBE | 07613327277517 | 79 |
| MX-PRO | 6082 | FPO | 07613327261547 | 78 |
| (unnamed) | 5407-120-070 | HBE | 07613327096675 | 78 |
| (unnamed) | 5407-120-970C | HBE | 07613327096521 | 78 |
| Prime Series | 1115 | FPO | 07613327278231 | 78 |
| SYNCHRO 2 | M00326010 | DQX | 04546540688729 | 78 |
| VARIAX | 657314S | HRS HTN HWC | 07613327086850 | 78 |
| VARIAX | 657316S | HRS HTN HWC | 07613327086881 | 78 |
| Ideal Eyes, Speed-Lock | 0502104030 | HRX | 07613327062113 | 77 |
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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