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U.S. Department of Health and Human Services

Class 2 Device Recall CPT

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 Class 2 Device Recall CPTsee related information
Date Initiated by FirmJuly 02, 2024
Date PostedJuly 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2450-2024
Recall Event ID 94923
510(K)NumberK960658 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
ProductCPT 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
Code Information 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
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information ContactCorporate Quality
574-371-3071
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce5,500 (US); 242,000 (OUS)
DistributionWorldwide - US Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JDI
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