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U.S. Department of Health and Human Services

Class 2 Device Recall M/L Taper

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  Class 2 Device Recall M/L Taper see related information
Date Initiated by Firm July 26, 2023
Date Posted September 07, 2023
Recall Status1 Open3, Classified
Recall Number Z-2519-2023
Recall Event ID 92889
510(K)Number K200823  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
Product M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)
Code Information Item Number: 00771100640, UDI-DI: 00889024131699, Lot Number: 65236202; Item Number: 00771100440, UDI-DI: 00889024131613, Lot Number: 65249215
Recalling Firm/
Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact 411 Technical Services
Manufacturer Reason
for Recall
The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.
FDA Determined
Cause 2
Mixed-up of materials/components
Action An URGENT MEDICAL DEVICE RECALL notification letter dated 7/26/23 was sent to customers. Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the recall notice and ensure documentation. 4. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form shall be returned even if you do not have affected products at your facility. 5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation. 6. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. Surgeon Responsibilities: 1. You are receiving this notice because you have implanted one of the impacted stems based on our records. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. It is anticipated that the fit of the stem would have been highly detectable, for example a physical size 4 stem sitting lower than expected in a bone prepared for size 6, or vice versa and the stem sitting proud. During surgery, the available offsets in femoral head implants may have provided the necessary flexibility to appropriate
Quantity in Commerce 24 units
Distribution Worldwide - US Nationwide distribution in the states of AL, CA, GA, MI, NJ, PA, TN, and WI. The countries of Brazil, Canada, Netherlands.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JDI and Original Applicant = Zimmer, Inc.