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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- 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 (2)
- 00-5926-014-01
- Lot 62455332
Distribution
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