Recall Z-2450-2024 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Zimmer, Inc.
CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00811400010 00811400100 00811400110 00811400200 00811400210 00811400218 00811400230 00811400300 00811400310 00811400318 00811400330 00811400400 00811400410 00811400420 00811400423 00811400426 00811400430 00811400500 00811400510 00811400530 00811401218 00811401318 00811404000 0081140
| Date | Jul 30, 2024 (initiated Jul 2, 2024) |
| Status | Open, Classified |
| Reason | Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF. |
| Root cause | Under Investigation by firm |
| Action | On July 2, 2024, the firm notified customers through Urgent Medical Device Correction letters. Customers were informed of the increased risk of postoperative periprosthetic femoral fracture (PFF). The firm will be updating the IFU to reflect the risk of PFF, with anticipated release by the end of August 2024. In addition, the firm will begin phasing out the device with a target of December 2024 to stop sales. The latest IFU can be viewed electronically at labeling.zimmerbiomet.com and entering the part number. If you have further questions or concerns, please call customer service at 574-371 |
| Quantity | 5,500 (US); 242,000 (OUS) |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960658 | COLLARLESS POLISHED TAPER HIP PROSTHESIS Zimmer, Inc., Jul 16, 1996 |