CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip

FDA device recall Z-1294-2023 · posted 2023-03-29 · Open, Classified

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the range of motion in flexion/extension being less than 100 degrees as recommended per an internationally recognized standard (ISO 21535:2009

Action taken

Zimmer Biomet issued Urgent Medical Device Correction letter on 2/27/23 via Fed'X .Letter to Distributors, Doctors, Risk Managers and states reason for recall, health risk and action to take: Hospital Responsibilities: 1. Review this field action notice and ensure that affected personnel are aware of the contents. 2. Complete Attachment 1 Certificate of Acknowledgement Form and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. 3. Retain a copy of the Attachment 1 Certificate of Acknowledgement Form with your field action notice records in the event of a compliance audit of your facility s documentation. 4. 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. Review this field action notice for awareness of the contents. 2. There are no specific patient monitoring instructions related to this notice that are recommended beyond your existing follow-up schedule. 3. Complete Attachment 1 Certificate of Acknowledgement Form and send to CorporateQuality.PostMarket@zimmerbiomet.com . 4. Retain a copy of the Attachment 1 Certificate of Acknowledgement Form with your field action notice records in the event of a compliance audit of your facility s documentation. 5. 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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LPH

Quantity affected

1,168 untits

Distribution

AL AZ CO FL LA MI OH OK TX Foreign: Canada

Date initiated

2023-02-27

Date posted

2023-03-29

Location

Warsaw, IN

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