PRI Femoral Impactor Block for knee prosthesis surgery recalled over foreign material

Recall date

April 30, 2015

Source

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

Official notice title

Zimmer, Inc. recalls PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument

Recall number

Z-1696-2015

FDA classification

Class II

Brand / firm

Zimmer, Inc.

Sold / distributed

Worldwide Distribution-US (nationwide) including PR and the states of AL, AZ, CA, CO, FL, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, and the countries of Canada, Korea, Singapore, Australia, Japan, Malaysia, India, Austria, Belgium, Canary Islands, Czech Republic, F…

Why it was recalled

Potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the assembled part following the autoclave sterilization process. The Master Bond epoxy serves as a secondary locking mechanism to fix the metal insert to the impactor head. Foreign material has been observed on the impactor block. This has the potential for a biological response.

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

What was recalled

PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument