Synthes recalls SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit (Product No. SE-2020-10) due to incorrect drill guide size that may cause improper bone preparation and damage. Affected users should contact Synthes for details.
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.
Synthes is recalling a specific implant drill kit because it has the wrong drill guide size. This could lead to improper bone preparation and damage when used with the included implants. The recall affects surgeons and medical professionals performing bone fixation procedures.
The drill kit contains an incorrect drill guide size that may not prepare bone properly for the implant. This can cause bone damage if the drill holes are placed incorrectly for the implant size.
Surgeons and medical professionals using this drill kit for bone fixation procedures are most at risk. The recall specifically targets users who have the product number SE-2020-10.
Check for the product number SE-2020-10 on the drill kit. The kit is used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation.
Reach out to Synthes for specific instructions on how to handle the recalled product.
The product number is SE-2020-10.
The drill kit contains the incorrect size drill guide that may not prepare bone properly for the implant, potentially causing bone damage.
The recall record does not specify a fix or remedy.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0098-2023 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0098-2023 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.
