FDA Medical Device Recalls (openFDA)
Zimmer, Inc.: CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty. Item Number: 01.01012.384
- Recall number
- Z-1294-2023
- Recalling firm
- Zimmer, Inc.
- Product
- CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty. Item Number: 01.01012.384
- Status
- Open, Classified
- Initiated
- 2023-02-27
- Posted
- 2023-03-29
- Terminated
- not on file
- Reason
- 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
- Root cause
- Under Investigation by firm
- Action
- 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
- Quantity
- 1,168 untits
- Distribution
- AL AZ CO FL LA MI OH OK TX Foreign: Canada
- Lot, serial or model codes
- GTIN Number: 00889024283268 All lots
- 510(k) numbers
- K993259
- PMA numbers
- not on file
- Product code
- LPH
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28