Skip to content

Zimmer Gender Solution Patello-Femoral Joint (PFJ) System… recallZ-2545-2014 · Zimmer, Inc. · initiated Jul 30, 2014

Class II Terminated All recalls posted in August 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-2545-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 30, 2014
Posted by the FDA
Aug 26, 2014
Recalling firm
Zimmer, Inc.
Quantity
15 units
Product code
KRR
FDA submissions
K070695
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 description

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

Code information (models, lots, serial numbers)

00-5926-014-01; Lot 62455332

Other devices under the same FDA submission

5 devices cleared under K070695 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page