Synthes recalls SPEED 15X12X12mm implants due to incorrect drill guide causing potential bone damage. Affected units have specific product numbers and dates.
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 its SPEED 15X12X12mm Continuous Compression Implant because it includes the wrong drill guide size. This could lead to improper bone preparation and damage if used with the included implant kit.
The implant comes with a drill guide that is the wrong size. When used with the included implant, this causes improper bone preparation, which can damage bone tissue during surgery.
Orthopedic surgeons and medical professionals using the implant during surgery are most at risk. Patients receiving this implant would not be directly affected by the recall.
Check for product number SE-1512 on the implant. Units sold between July 2021 and July 2027 have the specific lot numbers MSE220445 and MSE210184.
Look for product number SE-1512 and lot numbers MSE220445 (expiring 7/1/2027) or MSE210184 (expiring 8/1/2026) on the implant.
The implant contains the incorrect drill guide size, which can cause improper bone preparation and potential bone damage during surgery.
Check for product number SE-1512 and lot numbers MSE220445 (expiring 7/1/2027) or MSE210184 (expiring 8/1/2026).
The recall does not specify a remedy, so contact Synthes directly for guidance.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0099-2023 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0099-2023 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.
