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The Woodpecker

IMT Integral Medizintechnik AG · Model The Woodpecker · UDI-DI 07629999033979

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510(k) clearances

1,030

Adverse events (1 deaths)

Recalls

Facilities

Description

The Woodpecker is a pneumatically powered device whereby the surgeon can create a precisely reamed prosthesis bed in the medullary femur. The minimal impulses generated by the rasp machine reduce tension peaks, fissures and splintering. The low intraosseous pressure minimizes the risk of fat embolism syndrome substantially. The high-frequency axial impulses of the instrument substantially reduce operating time.

Recalls

Date	Firm	Reason
2023-02-14	Pro-Dex Inc	Incorrect Unique Device Identifier/GTIN code was used on product.
2016-10-06	The Anspach Effort, Inc.	Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06	The Anspach Effort, Inc.	Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-03-11	MicroAire Surgical Instruments, LLC	MicroAire discovered that 20 suspect Impactor instruments ( MicroAire Pneumatic Impactor) were shipped to end users and were missing the lock and unlock symbol markings on them.
2013-12-09	Aesculap, Inc.	Certain lots of the Aesculap Hi Line XXS handpiece (part # GB790R) were recalled due to a possible failure of the handpiece.
2008-02-21	Linvatec Corp.	Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister pack
2008-02-21	Linvatec Corp.	Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister pack
2008-02-21	Linvatec Corp.	Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister pack
2008-02-21	Linvatec Corp.	Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister pack
2008-02-21	Linvatec Corp.	Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister pack

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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.