Synthes recalls Hammertoe CCI Kit (part 46.239.001) due to drill pin incompatibility with template causing surgical delays or soft tissue damage. Affected units sold with lot numbers MHC220119/MHC220120.
Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate an alternative form of fixation. Additionally, there is a potential for adverse tissue reaction if the surgeon attempts to use the guide regardless of tight fit and plastic debris is created and ends up in the wound
Synthes is recalling its Hammertoe Continuous Compression Implant (CCI) Kit (part number 46.239.001) because a packaging error means the drill pin doesn't fit the included drill template. This could delay surgery or cause soft tissue damage if a larger incision is needed. The risk also includes potential tissue reactions if the guide is used improperly.
The drill pin in the kit is not compatible with the included drill template due to a packaging error. This can cause surgical delays or require a larger incision, risking soft tissue damage. Using the guide without checking the fit may also create plastic debris in the wound, leading to adverse tissue reactions.
Orthopedic surgeons who purchased the Hammertoe CCI Kit (part number 46.239.001) with lot numbers MHC220119 or MHC220120. Patients undergoing foot surgery are at risk if the kit is used without proper compatibility checks.
Check for the part number 46.239.001 on the kit. Affected units have lot numbers MHC220119 or MHC220120 and expire on June 1, 2027.
Verify the drill pin fits the included drill template before use; if not, do not proceed with surgery.
The drill pin is not compatible with the drill template due to a packaging error, which could cause surgical delays or soft tissue damage if a larger incision is needed.
Check if your kit has lot numbers MHC220119 or MHC220120; if so, verify drill pin compatibility with the template before use.
Yes, using the kit without confirming drill pin compatibility may cause soft tissue damage or adverse tissue reactions due to plastic debris in the wound.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0008-2023 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0008-2023 from Synthes. 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.
