Zimmer, Inc. recalls CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00

Recalled August 7, 2024 · FDA recall Z-2450-2024 · Zimmer

Hazard

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

Units

5,500 (US); 242,000 (OUS)

Sold at

Worldwide - US Nationwide distribution.

Description

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

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

Manufacturer(s)

Zimmer, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →