Zimmer, Inc.: Device Recall

Recall Details

Recall Number

Z-2450-2024

Classification

Class II

Product Type

Device

Recalling Firm

Zimmer, Inc.

Status

Ongoing

Date Initiated

07/02/2024

Location

Warsaw, IN, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

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

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 Pattern

Worldwide - US Nationwide distribution.

Other Recalls by Zimmer, Inc.

• Class II: Risk 12/02/2025
  Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
• Class II: Risk 12/02/2025
  Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
• Class II: Risk 12/02/2025
  Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
• Class II: Risk 12/02/2025
  Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
• Class II: Risk 12/02/2025
  Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

View all recalls by Zimmer, Inc. →