Stryker Instruments
1941 Stryker Way, Portage, MI, US
Registered product codes
101 product codes
Recent MDR events
59,658 on file
- SurgiCount+ Gauze, 4x4 16 Ply, RFID, Double XRAYJul 29, 2026Injury3015967359-2026-00451
- Smoke Evac. Pencil Coated PB,Non-SterileJul 28, 2026Malfunction3015967359-2026-00450
- SONOPET IQ UNIVERSAL ANGLED HANDPIECEJul 22, 2026Malfunction3015967359-2026-00448
- FOOTED ATTACHMENT 16MMJul 22, 2026Malfunction3015967359-2026-99333
- MICRODRILL STRAIGHT ATTACHMENTJul 22, 2026Malfunction3015967359-2026-99349
- ELITE Q 14CM ANGLED ATTACHMENTJul 22, 2026Malfunction3015967359-2026-99339
- ELITE 20CM ANGLED ATTACHMENTJul 22, 2026Malfunction3015967359-2026-99350
- Elite 12cm Angled AttachmentJul 22, 2026Malfunction3015967359-2026-99330
- ELITE Q 12CM STRAIGHT ATTACHMENTJul 22, 2026Malfunction3015967359-2026-99341
- ZIP 24 SURGICAL SKIN CLOSURE DEVICEJul 22, 2026Malfunction3015967359-2026-99346
Recalls
497 on file
- TerminatedNov 6, 2020
Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment during use.
View FDA record ↗ - TerminatedJan 28, 2020
Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
View FDA record ↗ - TerminatedJan 28, 2020
Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
View FDA record ↗ - TerminatedJan 28, 2020
Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
View FDA record ↗ - TerminatedApr 19, 2017
Product shipped proximate to or past the expiration date listed on the product label.
View FDA record ↗ - TerminatedDec 21, 2016
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
View FDA record ↗ - TerminatedDec 21, 2016
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
View FDA record ↗ - TerminatedDec 21, 2016
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
View FDA record ↗ - TerminatedDec 21, 2016
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
View FDA record ↗ - TerminatedDec 21, 2016
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
View FDA record ↗
Compliance history
Matched by FEI 3015967359.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.