Speed recallZ-0099-2023 · Synthes (USA) Products LLC · initiated Sep 27, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Synthes (USA) Products LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Error in labeling
What the company is doing
On September 27, 2022, the firm notified affected customers via urgent medical Device Recall letters. Customers were instructed to examine their inventory to determine if they have affected product and to quarantine them immediately - Customers should not use the recalled products. Customers should contact their DePuy Synthes Sales Consultant or call the customer support services at [email protected] to coordinate the return/credits of the subject products.
Recall details
- Recall number
- Z-0099-2023
- Status
- Open, Classified
- Initiated by the company
- Sep 27, 2022
- Posted by the FDA
- Oct 18, 2022
- Recalling firm
- Synthes (USA) Products LLC
- Quantity
- 94 US; 30 OUS
- Product code
- JDR
- FDA submissions
- K142292
- Distribution
- US Nationwide distribution.
Product description
SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
Code information (models, lots, serial numbers)
UDI-DI (GTIN): 00810633020166 Lot/Expiry MSE220445 7/1/2027 MSE210184 8/1/2026
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Speed SE-1512Synthes GmbH · Staple, Fixation, Bone1 recall6 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 90918).
- Z-0098-2023 · Open, ClassifiedSPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and managemen…
- Z-0100-2023 · Open, ClassifiedSPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
- Z-0101-2023 · Open, ClassifiedDePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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