Synthes (USA) Products LLC: 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.

Agency Publication Date: October 18, 2022

Affected Products

Product: 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

Lot Numbers:

MSE210237

Product: SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512

UDI-DI (GTIN): 00810633020166 Lot/Expiry MSE220445 7/1/2027 MSE210184 8/1/2026

Product: SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910

UDI-DI (GTIN): 00810633020111 Lot/Expiry MSE210240 7/1/2027

Product: DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001

UDI-DI (GTIN): 00810633022047 Lot/Expiry MHC200114 2/9/2026 MHC220117 3/2/2027

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90918

Status: Active

Manufacturer: Synthes (USA) Products LLC

Manufactured In: United States

Units Affected: 4 products (81; 94 US; 30 OUS; 96; 196)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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