The Recall Desk
ModerateFDA (Devices)·Z-1635-2015·Announced 2015-05-27

Stryker Triathlon Femoral Component Recalled for Sterile Barrier Seal Issues

Stryker Howmedica Osteonics is recalling 1,147 Triathlon femoral components because the inner blister seal strength may be below validated requirements, potentially affecting sterile shelf life.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a potential defect in sterile barrier integrity without reporting any specific illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures where harm has not yet been reported.

Plain-English summary

Stryker Howmedica Osteonics Corp. is recalling 1,147 units of the Stryker Orthopaedics Triathlon femoral component. These sterile components are used for total reconstructive replacement of the knee joint. The recall covers specific item numbers and lots distributed worldwide, including the United States (nationwide including Puerto Rico), Australia, Canada, China, Brazil, France, Hong Kong, India, Italy, Mexico, Netherlands, Singapore, South Africa, Sweden, and Spain.

The recall was initiated because the peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to the long-term shelf life of the sterile barrier. This defect could potentially compromise the sterility of the device over time.

Healthcare providers and facilities should check their inventory for the affected item numbers and lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to Stryker Howmedica Osteonics Corp. according to the company's instructions.

The recalled product

Product
Stryker Orthopaedics Triathlon femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint
Manufacturer
Stryker Howmedica Osteonics Corp.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
1,147

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Item number Lot number 5512-F-201 Lots JYET
  • KFVZ
  • KGLX
  • 5512-F-202 Lots IPPOP
  • JYKX
  • KHZL
  • KJDN
  • KJHI
  • KJKY
  • 5512-F-301 Lots JTJA
  • KKAE
  • KKNB
  • 5512-F-302 Lots JXXF
  • KEYD
  • KFBY
  • KFTZ
  • KFXT
  • KHAB
  • 5512-F-401 Lots JWGY
  • KIED

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Stryker Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Stryker Howmedica Osteonics Corp.

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Same hazard · sterility compromise

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