The Recall Desk
HighFDA (Devices)·Z-2545-2014·Announced 2014-09-03

Zimmer Patello-Femoral Knee Prosthesis Recalled for Forging Defects

Zimmer, Inc. is recalling 15 units of a specific knee prosthesis component because internal review found five raw material forgings with defects that were not segregated.

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 involves a structural defect in a medical implant (forged laps) which poses a risk of harm, but the source text does not report any injuries, illnesses, or fatalities, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Zimmer, Inc. is recalling 15 units of the Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. This product is a knee prosthesis component identified by code 00-5926-014-01 and lot 62455332.

The recall was initiated after an internal review identified that five PFJ implant forgings had 'forged laps' during the receiving inspection process for raw material. A forged lap is a defect that forms when metal folds over itself during forging. These five defective forgings were not segregated and were subsequently issued to final manufacturing.

The affected units were distributed worldwide, including in the United States (specifically in Hawaii, California, Georgia, Michigan, and Illinois) and in the countries of Taiwan, Belgium, Australia, France, Japan, and the United Kingdom. The source text does not specify instructions for consumers or patients regarding the next steps.

The recalled product

Product
Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis.
Manufacturer
Zimmer, Inc.
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 (2)

  • 00-5926-014-01
  • Lot 62455332

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically: