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Zimmer Gmbh recalls Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.
Recalled May 6, 2015 · FDA recall Z-1523-2015 · Zimmer
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. · FDA Class II
Units
30 units
Sold at
Distributed to the states of IN, GA, WI, MO, PA, KS, TN, and NY.
Description
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.
Product
Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.
Manufacturer(s)
Zimmer Gmbh
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →