Recall Z-0368-2017 ยท GFD Dermatome
Zimmer Surgical Inc
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.
| Date | Nov 5, 2016 (initiated Jul 4, 2016) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Process design |
| Action | 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 |
| Quantity | 1030 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.