FEI 2648666
Stryker Puerto Rico, Llc.
HWY. 3, KM. 131.2, ARROYO, PR, US
MDR events14All time
Recalls0All time
Registered products45
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
45 product codes
Recent MDR events
14 on file
- STRYKER 8442-107-530 IBUR 3.0MM PRECISION MATCH HEADMar 16, 2026MalfunctionMW5185347
- STRYKER 2.3MM TAPERED ROUTERMar 5, 2026InjuryMW5184775
- BONE SCREW 6.5MM 40MM LOW PROFILE HEXAGONAL TRIDENT II STERILE - LOG2479260Nov 12, 2025MalfunctionMW5178752
- STRYKER SAWBLADESep 29, 2025MalfunctionMW5176724
- ARTHROSCOPIC SHAVER BLADEMay 27, 2025MalfunctionMW5170822
- STRYKER / HARMONIC FOCUS SHEARSMay 1, 2025MalfunctionMW5169685
- STRYKER / HARMONIC FOCUS SHEARSMay 1, 2025MalfunctionMW5169686
- SCREW BONE, ANKLE, TITANIUMOct 7, 2024MalfunctionMW5160820
- STRYKER CINCHLOCK ANCHORNov 7, 2023MalfunctionMW5147914
- STRYKER CEMENTSep 19, 2023InjuryMW5145912
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 2648666.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Feb 20, 2026
Compliance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- ISO 13485:2016 Clause 7.5.6Feb 20, 2026
Planned results not consistently met during validation of processes
- ISO 13485:2016 Clause 8.2.5Feb 20, 2026
Suitable methods for monitoring and measuring QMS processes not applied
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.