Mako Surgical recalls RESTORIS MCK Tibial Baseplates with incorrect sizing labels that could lead to improper fit during knee replacement surgery. Affected items include specific sizes and lot numbers.
Incorrect product and/or label. Sizing is labeled incorrectly.
Mako Surgical is recalling RESTORIS MCK Tibial Baseplates used in knee replacements due to incorrect sizing labels. This could cause improper fit during surgery, potentially leading to complications.
Incorrect sizing labels could lead to using the wrong size baseplate during knee replacement surgery. This might cause improper fit, potentially leading to complications like instability or misalignment.
Surgical teams using RESTORIS MCK Tibial Baseplates for knee replacements are affected. Patients undergoing these procedures may be at risk if the wrong size is used.
Check for RESTORIS MCK Tibial Baseplate-RM/LL with specific sizes: Size 2 (Item # 180612, Lot # 26080317-01) or Size 7 (Item # 180617, Lot # 26150217-01).
Verify the size and lot number on the baseplate to confirm if it matches the affected models.
The recalled models are RESTORIS MCK Tibial Baseplate-RM/LL for Size 2 (Item # 180612, Lot # 26080317-01) and Size 7 (Item # 180617, Lot # 26150217-01).
No immediate stop is required; check the labels to confirm if your baseplate is affected.
The recall record does not specify a remedy, so contact Mako Surgical directly for guidance.
We’ve drafted a message you can send Mako Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1644-2018 — Mako Surgical Mako Surgical Hello, I own a Mako Surgical that is covered by recall Z-1644-2018 from Mako Surgical. 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.
