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

Recalled July 30, 2014 · FDA recall Z-2084-2014 · 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

3,623

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 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 →