Device Recall Stryker

17071877

General Hospital and Personal Use Devices

2

No

US Nationwide and Ireland, Japan, South Korea, UK

T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 || Sterile personal protection garment

Lot 2005060701.

General Hospital and Personal Use Devices

2

No

Nationwide, Australia and Canada.

Stryker PainPump1 5-Day Infusion Kit ; Product number 500-110-000.

Catalog Nos. 2199-2022, 2199-2028 and 2199-2032 All lots manufactured from May 30, 2012

Orthopedic Devices

2

Yes

Worldwide distribution. US nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, NJ, NY, OH, PA, TX, WA, WI, WV), Sweden, South Africa, Chile, Australia, New Zealand, Canada, United Kingdom, Switzerland, Colombia, and Poland.

Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile || Catalog Numbers 2199-2022, 2199-2028 and 2199-2032. || For use in total hip arthroplasty.

Model Number(s): 0607-687-000 0605-887-000 0605-687-000 0605-683-000  0607-687-000  Lot numbers: 16021012, 16027022, 16049012, 16061012, 16092012, 16107012, 16022012, 16028012, 16049022, 16063012, 16098012, 16109012, 16025012, 16028022, 16049032, 16063022, 16100012, 16109022, 16025022, 16033012, 16053012, 16070012, 16104012, 16113022, 16026012, 16041012, 16056012, 16070022, 16104022, 16113032, 16026022, 16048012, 16056022, 16074012, 16105012, 16118012, 16027012, 16048022, 16060012, 16088012, 16106012, 16118022 0605-887-000  Lot numbers: 16041012, 16040012, 16050012, 16057012, 16069012, 16078012, 16104012, 16112012, 16124012 0605-687-000  Lot numbers: 16041012, 16047012, 16111012 0605-683-000  Lot numbers: 16071012

Orthopedic Devices

2

Yes

Worldwide distribution. US nationwide, France, Netherlands, Spain, Italy, Canada, Israel, Romania, Switzerland, and United Kingdom.

Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and 0605-683-000. For bone cement. || Stryker AutoPlex System kits contain a cement mixer, cement injector, funnel, and an extension tube assembly whereby bone cement powder and liquid monomer are mixed inside a chamber and transferred into a cement injector automatically. The bone cement is then dispensed directly into a fracture site using the cement injector and introducer needle combination.

Catalog No: I-K3254TA00 Lot Nos: F6E13243, F6L13864, F6M14078, F6S14667, F6S14831, F6W15444, F6W15406, F7C15943, F7H16099 and F7L16994

Orthopedic Devices

2

Yes

Nationwide Distribution to FL, IN, LA, NC, PA, TN and UT

Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, || Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants