Z-1294-2023Class II

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

Name: Z-1294-2023 CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in...
Creator: Zimmer, Inc.
Published: 2023-02-27
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2023-02-27 / Open, Classified / root cause: labeling and UDI

FDA source

Zimmer, Inc. began a recall of 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 on 2023-02-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1294-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-27
Posted: 2023-03-29
Recalling firm: Zimmer GmbH
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
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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
Root cause tag: labeling and UDI
FDA 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 [email protected]. 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 [email protected]. 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 [email protected] . 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 in commerce: 1,168 untits
Distribution: AL AZ CO FL LA MI OH OK TX Foreign: Canada
Product codes and lots: GTIN Number: 00889024283268 All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1294-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1294-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-05	2023-03-29

Product code LPH

K993259Class IIInter-Op Durasul Acetabular Inserts/cocr Femoral HeadsSulzer Orthopedics, Inc. / cleared 2000-03-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)