Zimmer Gmbh recalls Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.

Recall date

March 18, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1523-2015

FDA classification

Class II

Brand / firm

Zimmer Gmbh

Sold / distributed

Distributed to the states of IN, GA, WI, MO, PA, KS, TN, and NY.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.