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
Zimmer is recalling CoCr Femoral: XS, 38/-8, Taper 12/14 models for total hip replacements. These parts may not provide enough range of motion as required by international standards, which could lead to improper hip function.
The recalled femoral head may not allow the recommended 100-degree range of motion in flexion and extension. This could result in improper hip movement during total hip replacement procedures, potentially causing discomfort or reduced mobility.
Patients who received this specific hip implant component during surgery are likely affected. Surgeons and medical staff who used these parts in procedures are also at risk.
Check if your hip implant has the model number 01.01012.384 or GTIN 00889024283268. All production lots are affected.
Reach out to Zimmer directly for guidance on next steps regarding your specific implant.
The recalled femoral head may not meet the required 100-degree range of motion standard for hip replacements, as per ISO 21535:2009.
Check for model number 01.01012.384 or GTIN 00889024283268 on your hip implant component. All production lots are affected.
Contact Zimmer directly for guidance on next steps regarding your specific implant.
We’ve drafted a message you can send Zimmer to request your refund or repair — edit it as you like.
Subject: Recall Z-1294-2023 — Zimmer Zimmer Hello, I own a Zimmer that is covered by recall Z-1294-2023 from Zimmer. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
