CLASS II Device recall · Reported 3 Sep 2014 · FDA Enforcement Report
Gender Solution Patello-Femoral Joint recalled by Zimmer
Zimmer is recalling Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea, distributed nationwide in the US. The recall was initiated on 30 Jul 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2545-2014
- FDA event ID
- 68934
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jul 2014
- FDA classified
- 25 Aug 2014
- Reported
- 3 Sep 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Hip & Knee Implants
Timeline
| 30 Jul 2014 | Recall initiated by company | |
| 25 Aug 2014 | Classified by FDA | +26 days |
| 3 Sep 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis.
Where it was distributed
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.
Questions about this recall
Is Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component recalled?
Yes. Zimmer recalled Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component on 30 Jul 2014. The recall is Class II and its status is Terminated. Recall number Z-2545-2014.
Why was it 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.
Which lots are affected?
00-5926-014-01; Lot 62455332
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |