The Recall Desk
HighFDA (Devices)·Z-0495-2015·Announced 2014-12-10

Zimmer PSI Knee System Recalled for Potential Misalignment Design Flaw

Zimmer CAS is recalling 15 PSI Knee System units due to a design flaw that could lead to misalignment during surgery.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a design flaw that could lead to misalignment in a medical device, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Zimmer CAS is recalling 15 units of the PSI Knee System, a prosthesis and orthopedic instrument system used to assist in the positioning of knee replacement components. The recall was initiated after an internal discovery found that MRI scans of some PSI knee guides involved additional rotation adjustments that could potentially lead to misalignment due to a design flaw.

The affected units were distributed in the United States in the states of Arizona, Colorado, Illinois, Oregon, and Washington. The specific lot codes and expiration dates for the recalled items range from May 8, 2014, to December 31, 2015.

Healthcare providers and facilities that have received these units should stop using them and contact Zimmer CAS for further instructions on how to return or replace the affected products.

The recalled product

Product
PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.
Manufacturer
Zimmer CAS
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
15

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 (16)

  • BKL0398L 20-8070-002-01
  • DHA0645L 20-8070-002-01
  • DHA0646R 20-8070-002-02
  • ECO0516L 20-8070-002-01
  • GHE0651R 20-8070-002-02
  • KAD0595L 20-8070-002-01
  • KWI0523R 20-8070-002-02
  • MHA0483L 20-8070-002-01
  • MHA0484R 20-8070-002-02
  • MKE0659R 20-8070-002-02
  • MMA0728R 20-8070-002-02
  • SSC0782L 20-8070-001-01
  • TCA0582L 20-8070-002-01
  • THO0803L 20-8070-002-01
  • TMA0760L 20-8070-002-01
  • Expiration dates 5/8/14-12/31/15

Distribution

Distributed in 5 states:

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