Z-2450-2024Class II

CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers...

Name: Z-2450-2024 CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers...
Creator: Zimmer, Inc.
Published: 2024-07-02
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2024-07-02 / Open, Classified / root cause: labeling and UDI

FDA source

Zimmer, Inc. began a recall of CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00811400010 00811400100 00811400110... on 2024-07-02. FDA classified it as Class II and gives the reason as "Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2450-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-02
Posted: 2024-07-30
Recalling firm: Zimmer GmbH
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
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On July 2, 2024, the firm notified customers through Urgent Medical Device Correction letters. Customers were informed of the increased risk of postoperative periprosthetic femoral fracture (PFF). The firm will be updating the IFU to reflect the risk of PFF, with anticipated release by the end of August 2024. In addition, the firm will begin phasing out the device with a target of December 2024 to stop sales. The latest IFU can be viewed electronically at labeling.zimmerbiomet.com and entering the part number. If you have further questions or concerns, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday, or email [email protected]. *** UPDATED 9/18/24: Follow-up communication was distributed to impacted US surgeons on September 18, 2024. This updated letter reflected FDA's Medical Device Safety Communication issued on September 17, 2024, which provided additional recommendations on the use of the affected product during the phase out period, including that surgeons should consider using an alternative prosthesis where possible. The FDA Safety Communication can be found here: https://www.fda.gov/medical-devices/safety-communications/zimmer-biomet-cpt-hip-system-femoral-stem-and-increased-risk-thigh-bone-fracture-fda-safety?utm_medium=email&utm_source=govdelivery. The updated letter also includes a plain language communication that may be provided to patients. The firm stated all US surgeons will be transitioned to alternative brands and the CPT Hip System Femoral Stem will be exited in the US by the end of October 2024.
Quantity in commerce: 5,500 (US); 242,000 (OUS)
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2450-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2450-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-07	2024-07-30

Product code JDI

K960658Class IICollarless Polished Taper Hip ProsthesisZimmer, Inc. / cleared 1996-07-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)