Synthes recalls SPEED 9X10X10mm Continuous Compression Implant (Product No. SE-0910) due to incorrect drill guide causing potential bone damage during surgery. Affected units sold with specific lot numbers.
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 type of surgical implant because it includes the wrong drill guide size. This could lead to improper bone preparation and potential bone damage if used incorrectly during surgery.
The implant comes with a drill guide that's the wrong size for the implant. When surgeons try to prepare the bone for the implant, this incorrect guide could cause improperly placed drill holes, potentially damaging the bone.
Surgical patients and medical professionals who use this specific implant during procedures. Those with the product's lot number MSE210240 are most at risk.
Check for the product name 'SPEED 9X10X10mm Continuous Compression Implant' with Product No. SE-0910. Look for lot number MSE210240 on the packaging or label.
Verify the product name, lot number, and expiry date on the packaging or label.
The SPEED 9X10X10mm Continuous Compression Implant with Product No. SE-0910 and lot number MSE210240.
There is potential for bone damage due to incorrectly placed drill holes for the implant included in the sterile kit.
The recall record does not specify a remedy.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0100-2023 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0100-2023 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.
