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

FDA device recall Z-2545-2014 · posted 2014-08-26 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

KRR

Quantity affected

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.

Date initiated

2014-07-30

Date posted

2014-08-26

Date terminated

2015-01-20

Location

Warsaw, IN

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