Howmedica recalls Dall Miles SM GRIP and 2.16mm Homog CBL with catalog number 6704-0-110 due to potential Tyvek lid de-bonding from sealed package. Affected units sold with specific UDI and lot numbers.
There is a potential for the outer Tyvek lid to de-bond from the sealed package.
Howmedica is recalling Dall Miles SM GRIP and 2.16mm Homog CBL products with catalog number 6704-0-110 because the outer Tyvek lid might separate from the sealed package. This could lead to the product being exposed to contaminants or damage, though it doesn't pose an immediate safety risk.
The outer Tyvek lid may separate from the sealed package, potentially exposing the product to contaminants or causing damage. This could affect the product's sterility or functionality, but it does not pose a direct risk of injury or harm to users.
Owners of Dall Miles SM GRIP and 2.16mm Homog CBL products with catalog number 6704-0-110 and UDI 07613327013306 are affected. Patients using these products for medical purposes may be at slightly higher risk if the lid separates.
Check for the catalog number 6704-0-110 on the product label. The unique device identifier (UDI) 07613327013306 and lot number 87458602 are also associated with this recall.
Look for the catalog number 6704-0-110 on the product label to confirm if it is affected.
The product is safe to use as long as the Tyvek lid remains attached to the package. If the lid separates, it may need to be discarded or replaced.
If the Tyvek lid separates from the package, contact Howmedica for guidance on whether to discard or return the product.
Check the product label for catalog number 6704-0-110 and unique device identifier (UDI) 07613327013306.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-0645-2022 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-0645-2022 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.
