Z-2545-2014 Class II Terminated
FDA device recall Z-2545-2014 was initiated by Zimmer, Inc. on Jul 30, 2014 and is designated Class II. 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… The recall status is terminated (terminated Jan 20, 2015). Affected quantity: 15 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 3, 2014
- Initiation Date
- Jul 30, 2014
- Termination Date
- Jan 20, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 units
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.
Distribution Pattern
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.
Code Information
00-5926-014-01; Lot 62455332
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2545-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026