Lower riskMedical device recall · FDA · Published February 27, 2023
Zimmer CoCr Femoral Head XS Recall: Risk of Reduced Hip Mobility
Zimmer recalls CoCr Femoral Head XS models due to potential reduced hip mobility. Affected units may not meet ISO 21535:2009 standards for range of motion. Contact Zimmer for details.
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
Take action
Contact the company
📍Recalling firmZimmer, Inc.1800 W Center St · Warsaw, IN 46580-2304
“Zimmer CoCr Femoral Head XS Recall: Risk of Reduced Hip Mobility.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58847-zimmer-cocr-femoral-head-xs-recall-risk-of-reduced-hip. Based on FDA recall #Z-1294-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1294-2023%22&limit=1).
The FDA announced on Feb. 27, 2023, that Zimmer, Inc. is recalling CoCr Femoral Head units due to compatibility issues with specific acetabular liners. The agency said the hazard involves a range of motion less than the recommended standard.
The recall addresses the need to update the compatibility matrix in the Instructions for Use because the CoCr Femoral Head XS has a range of motion in flexion/extension of less than 100 degrees. This is below the recommendation per the internationally recognized standard ISO 21535:2009 when used with Epsilon Durasul Constrained Acetabular Liners.
Context
GovInfoNow's records show Zimmer, Inc. has had 19 other recalls since Aug. 25, 2022. Recent issues include plastic guide breakage in the Off-Axis Shoulder System Guide recalled on May 20, 2026, and posterior augment packaging errors in the Persona Revision Femoral Distal Augment recalled on May 11, 2026. Other recent recalls of similar products include the U2 Total Knee System Femoral Valgus Adaptor (May 20, 2026), the U2 Total Knee System Femoral Offset Bushing (March 19, 2026), and the Zeiss Intrabeam Spherical Applicator (June 1, 2026).
How to tell if you have this one
Check if your hip implant has the model number 01.01012.384 or GTIN 00889024283268. All production lots are affected.
Brand
Zimmer
Product
CoCr Femoral Head, XS, 38/-8, Taper 12/14
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Zimmer
Reach out to Zimmer directly for guidance on next steps regarding your specific implant.
Where it went and when
Where it was distributed
Distributed in 9 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “AL AZ CO FL LA MI OH OK TX Foreign: Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1294-2023 (February 27, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1294-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.