Recall Z-2545-2014 ยท KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Zimmer, Inc.
Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis.
| Date | Aug 26, 2014 (initiated Jul 30, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070695 | ZIMMER PATELLOFEMORAL JOINT PROSTHESIS Zimmer, Inc., Jun 7, 2007 |