Zimmer, Inc.: CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00811400010 00811400100 00811400110 00811400200 00811400210 008114002

Hazard

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

Details from the source

Reason for recall: Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF. Distribution: Worldwide - US Nationwide distribution. Quantity: 5,500 (US); 242,000 (OUS) Lot/code info: 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

UPC codes

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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.