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.
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📍Recalling firmSynthes (USA) Products LLC1301 Goshen Pkwy · West Chester, PA 19380-5986
“Synthes SPEED 9X10X10mm Implant Recall: Incorrect Drill Guide Risks Bone Damage.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60007-synthes-speed-9x10x10mm-implant-recall-incorrect-drill-guide-risks-bone. Based on FDA recall #Z-0100-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0100-2023%22&limit=1).
The FDA announced on September 27, 2022, that Synthes (USA) Products LLC is recalling the SPEED 9X10X10mm Continuous Compression Implant due to a hazard of potential bone damage. The recall involves Product No. SE-0910 distributed nationwide in the United States.
The products contain an incorrect size drill guide that will not prepare the bone correctly for the included implant. 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.
Context
GovInfoNow's records show Synthes (USA) Products LLC has 19 other recalls on record since July 21, 2017. Other recent recalls of similar products include Synthes 2.4V TAP CORTEX SCREW Recall: Incorrect Thread Hazard (February 25, 2026), Synthes LOW PROF LCKNG SCREW: Incorrect Length Labeling on Packaging (September 26, 2025), and Synthes Stardrive Screwdrivers May Cause Surgical Delay - Recall (April 25, 2024). Other recent recalls of similar products include Orthalign Drill Plate Recall: Bone Cut Risk from Manufacturing Defect (February 10, 2026), Orthalign Drill Plate Recall: Risk of Bone Cut in Normal Use (February 10, 2026), and Straumann Bone Level Tapered Implant May Be Wrong Length - Recall (July 16, 2026).
How to tell if you have this one
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.
Brand
Synthes
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution.
Recall number
Product, codes & lots
Quantity
Z-0098-2023
SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and management of fracture and reconstructive surgery.; UDI-DI (GTIN): 00810633020494 Lot MSE210237 Expiry 11/1/2026
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.
Official source: FDA Recall #Z-0100-2023 (September 27, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0100-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.