CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 008
FDA device recall Z-2450-2024 · posted 2024-07-30 · Open, Classified
Recall details
- Recalling firm
- Zimmer, Inc.
- 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.
- Action taken
- 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 CorporateQuality.PostMarket@zimmerbiomet.com. *** 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- JDI
- Quantity affected
- 5,500 (US); 242,000 (OUS)
- Distribution
- Worldwide - US Nationwide distribution.
- Date initiated
- 2024-07-02
- Date posted
- 2024-07-30
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COLLARLESS POLISHED TAPER HIP PROSTHESIS (K960658) | Zimmer, Inc. | 1996-07-16 |