Recall Z-2545-2014— Zimmer, Inc.

Name: FDA recall Z-2545-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-30

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2014-07-30, terminated 2015-01-20. It names one FDA 510(k) clearance: K070695. Product: Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis.. Reason: 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..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-07-30
Terminated: 2015-01-20
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K070695 — ZIMMER PATELLOFEMORAL JOINT PROSTHESISZimmer, Inc.·cleared 2007-06-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.