Z-2545-2014Class II

Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size...

Name: Z-2545-2014 Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size...
Creator: Zimmer, Inc.
Published: 2014-07-30
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-07-30 / Terminated / root cause: manufacturing process

FDA source

Zimmer, Inc. began a recall of Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis on 2014-07-30. FDA classified it as Class II and gives the reason as "Internal review found that five (5) PFJ implant forgings were identified as have forged laps during receiving inspection process for raw material. These five forgings were not segregated and were subsequently issued to...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2545-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-30
Posted: 2014-08-26
Terminated: 2015-01-20
Recalling firm: Zimmer GmbH
Product: Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis.
Product code: KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Reason for recall: Internal review found that five (5) PFJ implant forgings were identified as have forged laps during receiving inspection process for raw material. These five forgings were not segregated and were subsequently issued to final manufacturing under Part 00-5926-014-01; lot 62455332. A forged lap is a defect that forms when metal folds over itself during forging.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Zimmer sent an URGENT MEDICAL DEVICE RECALL letter dated July 2014 to affected distributors and hospital accounts. The letter identified the affected product, problem and the actions to be taken. The letter instructed customers to 1. Review the notification and ensure affected personnel are aware of the contents, 2. Locate and quarantine any affected product listed above and notify your Zimmer sales representative, and 3. Your Zimmer sales representative will remove the recalled product from your facility. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.
Quantity in commerce: 15 units
Distribution: Worldwide Distribution - US (nationwide) in the states of HI, CA, GA, MI, and IL and the countries of TAIWAN, BELGIUM, AUSTRALIA, FRANCE, JAPAN, and UK.
Product codes and lots: 00-5926-014-01; Lot 62455332

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2545-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2545-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-25

Product code KRR

K070695Class IIZimmer Patellofemoral Joint ProsthesisZimmer, Inc. / cleared 2007-06-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)