Howmedica recalls certain Mako Restoris MCK Baseplate Trials (Size 5) with incorrect laser markings for surgical use. This may affect partial knee arthroplasty procedures.
Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
Howmedica is recalling specific Mako Restoris MCK Baseplate Trials (Size 5) that have incorrect laser markings. This could lead to improper surgical implantation during partial knee replacements.
The baseplate trials have incorrect laser markings, which could lead to improper surgical implantation during partial knee replacements. This might cause the implant to be placed incorrectly, potentially affecting the surgery's outcome.
Surgical teams using the recalled baseplate trials for partial knee arthroplasty procedures. Patients undergoing these surgeries are at risk if the incorrect marking causes improper implantation.
Check for the product name 'Mako Restoris MCK Baseplate Trial (Size 5 RM/LL)', reference number '170615', and lot number '26270421' on the packaging or documentation.
Verify the product name, reference number, and lot number on the packaging or documentation.
The recall indicates incorrect laser markings, which could lead to improper surgical implantation. The product is not safe for use without verification.
The recall does not specify a remedy, so check the product details and contact Howmedica for further guidance.
Look for the product name 'Mako Restoris MCK Baseplate Trial (Size 5 RM/LL)', reference number '170615', and lot number '26270421' on the packaging or documentation.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-1385-2023 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-1385-2023 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.
