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Osteotec Silicone Finger - Distal Rasp Size 9

OSTEOTEC LIMITED · Model OSTF-9D · UDI-DI 05060183094789

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510(k) clearances

4,703

Adverse events (2 deaths)

Recalls

121

Facilities

Description

The 11 distal (blue handle) and 11 proximal (whithe handle) rasps are device specific instruments used to create bone cavities for the implantation of the Osteotec Silicone Finger Implant. Each rasp is dedicated to a particular size of implant and is based on the design of the proximal or distal stem.

Recalls

Date	Firm	Reason
2017-04-23	Greatbatch Medical	Greatbatch Medical has voluntarily initiated a Recall for the Linear Straight Broach Handle (Rasp Handle) and EZ Clean" Linear Broach Handle. Greatbatch Medical has received report
2011-04-21	Encore Medical, Lp	Strike plate may dislodge from the broach stem handle during impaction of the device.
2009-04-29	Zimmer Inc.	The broach handle may fracture at the threaded tip during use, which would result in surgical intervention to retrieve the broach or the trial as the threaded tip fragment prevents
2009-03-13	Zimmer Inc.	The surface finish inside of the broach is not to specification and the instrument may corrode if cleaned and sterilized according to instructions.
2008-01-25	Stryker Howmedica Osteonics Corp.	Rejuvenate Broach system was designed in a manner that may result in the potential for a medical calcar fracture.

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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.