Medacta recalls specific MiniMAX cementless hip stems due to packaging breaches reported in complaint monitoring. Affected units have unique reference and GTIN numbers listed in the recall notice.
Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem.
Medacta is recalling certain MiniMAX cementless hip stems because packaging has been reported to be breached. This could lead to improper use during surgery if the stem is not properly secured.
Packaging breaches could mean the stem is not properly secured during surgery. This might lead to improper implantation or complications during the procedure if the stem is not correctly positioned.
Patients who received the recalled hip stems for total or partial hip replacement surgery are affected. Surgeons and medical staff using these stems during procedures are at risk if the packaging is compromised.
Check for reference codes like REF 01.13.100L through REF 01.13.108R with corresponding GTIN numbers listed in the recall notice. Units produced before lot number 169041 also have the older packaging.
Look for reference codes and GTIN numbers listed in the recall notice to identify affected units.
The recall is due to packaging breaches reported in complaint monitoring, which could affect proper implantation during surgery.
Check for reference codes like REF 01.13.100L through REF 01.13.108R with corresponding GTIN numbers listed in the recall notice. Units with lot numbers less than 169041 also have the older packaging.
No action is required if the packaging is intact. Only check for packaging breaches as described in the recall notice.
We’ve drafted a message you can send Medacta to request your refund or repair — edit it as you like.
Subject: Recall Z-0196-2019 — Medacta Medacta Hello, I own a Medacta that is covered by recall Z-0196-2019 from Medacta. 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.