Medical Device Recall: CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00811400010 00811400100 00811400110 00811400200 00811400210 00811400218 0081
Zimmer, Inc. · July 2, 2024
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.
Product Description
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
Distribution
Worldwide - US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
5,500 (US); 242,000 (OUS)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2450-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.