Howmedica Osteonics recalls certain Mako Restoris MCK Baseplate Trials (Size 6) due to incorrect laser marking that may affect surgical accuracy. Affected units include specific lot numbers and reference codes.
Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
Howmedica Osteonics is recalling specific Mako Restoris MCK Baseplate Trials (Size 6) because they have incorrect laser markings. This could lead to surgical errors during partial knee replacements if used without proper verification.
The incorrect laser marking on the baseplate could cause misalignment during surgery. This might result in improper knee joint positioning if the surgeon relies on the markings for surgical guidance.
Surgical teams using the recalled baseplate trials for partial knee replacements are affected. Patients undergoing surgery with these specific units are at risk of inaccurate implant placement.
Check for the product name 'Mako Restoris MCK Baseplate Trial (Size 6 RM/LL)', reference number '170616', and lot number '26250421'. The product was sold with GTIN 00848486003753.
Check the product's reference number (170616) and lot number (26250421) to confirm if it is affected.
The recalled product is the Mako Restoris MCK Baseplate Trial (Size 6 RM/LL) with reference number 170616 and lot number 26250421.
Check for the reference number 170616 and lot number 26250421 on the product label. The product was sold with GTIN 00848486003753.
The recall record does not specify a remedy, so contact Howmedica Osteonics directly for guidance.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-1386-2023 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-1386-2023 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.
