DePuy Synthes recalls specific hammertoe implants due to incorrect drill guide causing potential bone damage. Affected products have Product No. 46.239.001 and UDI-DI 00810633022047.
The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.
DePuy Synthes is recalling hammertoe implants with Product No. 46.239.001 because they contain the wrong drill guide size. This could lead to improper bone preparation and potential bone damage if used incorrectly.
The implants come with an incorrect drill guide size that won't properly prepare the bone for the implant. If the wrong drill guide is used, it can cause misaligned drill holes, leading to potential bone damage during surgery.
Orthopedic patients who received the specific implant product with Product No. 46.239.001 are most at risk. Patients using these implants for hammertoe correction may experience bone damage if the drill guide is used incorrectly.
Check for Product No. 46.239.001 on the implant packaging. The UDI-DI (GTIN) is 00810633022047. These implants were sold with specific lot dates: MHC200114 (2/9/2026) and MHC220117 (3/2/2027).
Look for Product No. 46.239.001 and UDI-DI 00810633022047 on the implant packaging.
DePuy Synthes Hammertoe Continuous Compression Implants with Product No. 46.239.001 and UDI-DI 00810633022047.
The incorrect drill guide size may cause improper bone preparation, leading to potential bone damage if the implant is used incorrectly.
The recall does not require immediate discontinuation; however, patients should check if they have the recalled product and contact their surgeon for guidance.
We’ve drafted a message you can send DePuy Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0101-2023 — DePuy Synthes DePuy Synthes Hello, I own a DePuy Synthes that is covered by recall Z-0101-2023 from DePuy 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.
