FDA-Device2015-05-06Class II
Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.
Zimmer Gmbh
Hazard
Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of the two components). This has the potential for delay in surgery.
Sold states
Distributed to the states of IN, GA, WI, MO, PA, KS, TN, and NY.
Affected count
30 units
Manufactured in
Sulzer Allee 8, Winterthur, Switzerland
Products
Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1523-2015Don't want to check this manually?
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