Howmedica recalls custom implant systems made between March 2007 and October 2014 due to outdated instructions that don't clarify locking mechanism function and warnings for the locking screw. Affected users should contact the company for details.
From March 2007 to October 2014, product did not contain updated instructions for use (IFU) to clarify the function of locking mechanism and warnings related to the locking screw.
Howmedica is recalling custom-made implant systems with Minimum Invasive Grower (MIG) components produced from March 2007 to October 2014. The recall is because the product did not include updated instructions that clearly explain how the locking mechanism works and warn about the locking screw.
The product lacked updated instructions that clarify the function of the locking mechanism and warnings about the locking screw. This could lead to improper use if the user follows outdated guidance without understanding the critical safety features.
Patients who received the custom implant system with MIG component between March 2007 and October 2014 are likely affected. Those who have the implant and follow the outdated instructions may face misunderstandings about the locking mechanism.
Check for the Prosthesis Identification Number (PIN) listed in the recall: 16082, 18313, 18666, 18713, or 18800. The implant was manufactured between March 2007 and October 2014.
Reach out to Howmedica Osteonics Corp. for specific details about your implant and instructions.
The product did not contain updated instructions for use that clarify the function of the locking mechanism and warnings related to the locking screw.
Contact Howmedica Osteonics Corp. for details about your specific implant and instructions.
The implant was manufactured between March 2007 and October 2014.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-2567-2018 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-2567-2018 from Howmedica. 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.
