Device Recall Zimmer Air Dermatome II Handpiece Loaner 의 리콜

Recall

75483

Class 2

Z-0368-2017

2016-07-04

2016-11-05

Terminated

United States

2017-06-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150475

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.

The firm, Zimmer Biomet Surgical, sent an "URGENT MEDICAL DEVICE RECALL CORRECTION NOTICE" dated 7/6/2016 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Carefully review this letter and ensure all users of the Zimmer Air Dermatome II at your facility have been informed of this notice. 2. Inspect the Zimmer Air Dermatome II devices within your facility and indicate on the attached Certificate of Acknowledgment the condition of the device. Complete and sign the attached Certificate of Acknowledgment and return it to corporatequality.postmarket@zimmerbiomet.com. 3. Before each use, continue to examine the surface coating for blistering/peeling. If the blistering/peeling characteristics are not present, you may continue to use. Immediately after each use, re-examine the surface coating for blistering/peeling. If the blistering/peeling characteristics are present, discontinue use. In the event that alternate devices or therapies are not available, surgeons may, at their discretion, determine the use of the device as a medical necessity and continue to use. After use, follow your facilitys wound irrigation protocol or Zimmer Biomet recommends copious irrigation with a normal saline solution or immersion of the graft in a bowl of normal saline. Zimmer Biomet recommends irrigating the donor site with saline as well. Carefully examine the skin graft and donor site for gray coating flakes and continue to irrigate as necessary. Report this as an adverse event to Zimmer Biomet Surgical at SurgicalRegulatoryReporting@zimmerbiomet.com. If after reviewing this notification you have further questions or concerns please call 1-330-364-0989 between 8:00 am and 5:00 pm EST, Monday through Friday.