Device product

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 00811405000

Z-2450-2024

July 02, 2024

Class II

Product summary

Firm: Zimmer, Inc.
Event: Event 94923
Status: Ongoing
Classification: Class II
Quantity: 5,500 (US); 242,000 (OUS)
Official record key: device-enforcement:Z-2450-2024

Official wording

Reason: Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF.

Code information: Item Number / UDI-DI 00811400000 / 00889024145733 00811400010 / 00889024145740 00811400100 / 00889024145757 00811400110 / 00889024145764 00811400200 / 00889024145771 00811400210 / 00889024145788 00811400218 / 00889024145795 00811400230 / 00889024145801 00811400300 / 00889024145818 00811400310 / 00889024145825 00811400318 / 00889024145832 00811400330 / 00889024145849 00811400400 / 00889024145856 00811400410 / 00889024145863 00811400420 / 00889024145870 00811400423 / 00889024145887 00811400426 / 00889024145894 00811400430 / 00889024145900 00811400500 / 00889024145917 00811400510 / 00889024145924 00811400530 / 00889024145931 00811401218 / 00889024145948 00811401318 / 00889024145955 00811404000 / 00889024145962 00811405000 / 00889024145979

Distribution pattern: Worldwide - US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF.