DePuy Orthopaedics, Inc. recalls RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthoped

Recalled July 30, 2014 · FDA recall Z-2083-2014 · DePuy Orthopaedics

Hazard

The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming. · FDA Class II

Units

10,467 units

Sold at

Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WV and Internationally to AUSTRALIA, AUSTRIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IBERIA, IRELAND, ISRAEL, ITALY, NEW ZEALAND, NORWAY, POLAND, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND & UK.

Description

The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming.

Product

RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

Manufacturer(s)

DePuy Orthopaedics, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →