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Osteotec SFI Instruments

OSTEOTEC LIMITED · Model OSTF-Ins · UDI-DI 05060183095793

LXH Prescription

510(k) clearances

81,662

Adverse events (55 deaths)

526

Recalls

1,117

Facilities

Description

The Osteotec SFI Instruments device are a non-active, non-implantable, invasive device intended to be used as a tool for creating the correct size of cavity in the medullary canal to enable implantation of the Osteotec Silicone Finger Implant prosthesis during arthroplasty to replace the metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The Osteotec SFI Instruments are available in eleven evenly scaled sizes, numbered from size 00 to size 9, to match the available sizes of the definitive implant, the Osteotec Silicone Finger Implant. Each size has 2 rasps, one for creation of the proximal cavity and one for the distal cavity, therefore 22 rasps in total. The instrument set also includes an Awl, this creates an initial indent for the rasps to open up in stages. These eleven sizes and the Awl effectively constitute components of the Osteotec SFI Instruments, which is placed on the market as a single medical device.

Recalls

Date	Firm	Reason
2026-07-01	Biomet, Inc.	Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused
2026-07-01	Biomet, Inc.	Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused
2026-07-01	Biomet, Inc.	Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused
2026-07-01	Biomet, Inc.	Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused
2026-07-01	Biomet, Inc.	Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused
2026-05-20	United Orthopedic Corp.	Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
2026-05-20	United Orthopedic Corp.	Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
2026-03-19	United Orthopedic Corp.	Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
2025-03-28	Stryker GmbH	The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
2025-03-28	Stryker GmbH	The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.