Recall Z-2225-2011 ยท GFD Dermatome
Integra LifeSciences Corp.
Universal Power Supply Units, Part Number DP0007 and DP0800 , for use with the Integra Padgett Dermatomes - Model S, SB, and S6, Device Listing #E208841, 510 (k) exempt. The Integra Padgett Dermatomes are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. The Model S and S6 dermatomes are intended for professional use in hospitals, and similar medical
| Date | May 20, 2011 (initiated Mar 11, 2011) |
| Status | Terminated |
| Reason | Dermatome power supply units distributed by the recalling firm may not meet the required medical device electrical safety regulations which can result in an increased potential for electric shock to the device user and/or patient. |
| Root cause | Other |
| Action | Integra LifeSciences Corp. initiated their recall by contacting their Sales Representatives via telephone conference calls on 3/10/2011. Separate written recall communications, in the form of an 'URGENT PRODUCT RECALL NOTIFICATION' were provided via E-mail and FedEx to the firm's Sales Representatives on 3/11/2011; and to their hospital and distributor customers on 3/11/2011; 3/14/2011; and on 4/12/2011. The recall notification addressed to the non-Integra Sales Rep customers informs the customers of the problem with the power supply units (that they may not meet the required medical device |
| Quantity | 892 units were distributed in the U.S & 155 units were distributed in foreign countries |
| Distribution | Worldwide Distribution - USA including FL, CO, IL, AR, MD, IN, CA, MT, AZ, NY, LA, TX, MA, MO, CT, MI, NE, OH, NC, WV, VA, PA, NJ, TN, UT, MN, OK, WI, GA, AL, WA, KS, OR, AK, DC, SC, NE, MS, RI, NV, IA, and ND and the country of Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.