Zimmer Surgical Inc recalls Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged inside of a padded-foam corru…

Recall date

July 4, 2016

Source

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

Recall number

Z-0368-2017

FDA classification

Class II

Brand / firm

Zimmer Surgical Inc

Sold / distributed

US Nationwide Distribution including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, and WI.

Why it was recalled

Zimmer Biomet Surgical has received product complaints reporting that the surface coating applied to the device is blistering, peeling and discoloring after usage over time (see Image 1). There have been no injuries associated with the reported complaints. In addition, an independent assessment determined that the blistering, peeling and potentially flaking of the surface coating is not expected to result in any long range health consequences. Given that the frequency of this surface coating condition can worsen with age, Zimmer Biomet Surgical is currently making preparations for replacement activities to follow in order to prevent future complaints. This document is provided to alert all users of the potential for the surface coating to exhibit blistering, peeling, and discoloring after usage over time. A separate recall removal notice will be issued to facilities, in phases, with detailed instructions beginning in August 2016. Your sales representatives will be notified when a replacement is ready. Do not return product at this time as part of this action. Image 1.

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

What was recalled

Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope.