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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.
BrandModelProduct codesPrimary DILinked events
Neptune0703001000FYD JCX07613327116656183
SYNCHRO 2M00326410DQX04546540688767173
(unnamed)4100400000HWE04546540068323167
GoBedFL28EXFNL07613327169386165
(unnamed)5100120470ERL04546540369963165
(unnamed)5407-FA2-000HBE07613327096392163
(unnamed)5100120482ERL04546540369994161
(unnamed)1089FPO07613327278170161
Altrix8001DWJ FLL07613327277555155
Neptune0703046000GEI07613327117189153
(unnamed)5407FA2023HBE07613327096729144
(unnamed)5400121000ERL04546540402028143
AXSOS702753LXH07613327005028142
InTouch2141FNL07613327385427142
(unnamed)5407-120-450HBE07613327096545141
COBRA3910900093NBH07613327413595138
Stryker SmartLife7222120000HWE07613327128789136
s33005FNL07613327278347135
Neptune0703047000GEI07613327117202134
CUBFL19HFMS07613327169348125
(unnamed)5100015250EIA04546540380272123
PRO703966LXH07613252719861123
(unnamed)5407-120-472HBE07613327096576122
(unnamed)4100062000HWE04546540068354120
Excelsior SL-10M0031681890DQY04546540688217119
GoBedFL28CFNL07613327169355119
REUNION5901-1168KWS07613327101027119
(unnamed)5407-120-482HBE07613327096590118
(unnamed)4701HDD07613327278095117
XIA 348230000KWP MNH MNI NKB OSH04546540560193117
Showing 31–60 of 36,412← PrevNext →
Compliance actions
FDA warning letters and enforcement actions (full history).
DateTypeActionFirm
2017-04-06WLWarning LetterEntellus Medical Inc.
2015-04-08WLWarning LetterThermedx LLC
2013-11-26INJInjunctionPhysio-Control, Inc.
2013-03-06WLWarning LetterStryker Corporation
2013-03-06WLWarning LetterStryker Corporation
Facilities
Registered establishments with their latest FDA inspection outcome.
FEINameLocationLast inspectionWatch
3020163307Stryker Tijuana OperationsTijuana Baja California, MX—
3012497308Stryker US Supply Chain OperationsPlainfield, IN, US—
3007495879THERMEDX, LLCSolon, OH, USVAI
3001237463TMJ Solutions, LLCSan Buenaventura, CA, USNAI
3004983210TORNIER Inc.Columbia City, IN, USNAI
3008388276TORNIER S.A.SMontbonnot Saint-Martin Isere, FR—
3000718467TORNIER, INC.Bloomington, MN, USNAI
3003902387TORNIER, SASGRENOBLE CEDEX 1 Isere, FR—
3000931034Tornier S.A.S.Montbonnot Saint-Martin Isere, FRVAI
1043534WRIGHT MEDICAL TECHNOLOGY, INC.Arlington, TN, USVAI
3010667733WRIGHT MEDICAL TECHNOLOGY, INC.Arlington, TN, USVAI
Showing 51–61 of 61← Prev