—#202821

Product

M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)

FDA product code: JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K200823
Affected lot / code info: Item Number: 00771100640, UDI-DI: 00889024131699, Lot Number: 65236202; Item Number: 00771100440, UDI-DI: 00889024131613, Lot Number: 65249215

Why it was recalled

The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

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

Recalling firm

Firm: Zimmer, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Worldwide - US Nationwide distribution in the states of AL, CA, GA, MI, NJ, PA, TN, and WI. The countries of Brazil, Canada, Netherlands.

Timeline

Recall initiated: 2023-07-26
Posted by FDA: 2023-09-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #202821. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.