The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities

Reason: This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate intermittently. Zimmer's investigation determined that the planetary gear teeth were broken. This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site.

Code information: Serial Number 100211, 100338, 100515, 100560, 100647, 100755, 101104, 101345, 101562, 101769, 101890, 101983, 102560, 103407, 103509, 103816, 104529, 104863, 105049, 105072, 105604, 106394, 106474, 106624, 107861, 108103, 108203, 108210, 108339, 108911, 109445, 109543, 110034, 110837, 111046, 111047, 111048, 111049, 111050, 111051, 111052, 111053, 111054, 111055, 111056, 111057, 111058, 111059, 111060, 111061, 111062, 111063, 111064, 111065, 111066, 111067, 111068, 111069, 111071, 111072, 111073, 111074, 111075, 111076, 111079, 111081, 111083, 111084, 111085, 111086, 111087, 111089, 111090, 111091, 111092, 111096, 111100, 111101, 111102, 111104, 111105, 111116, 111121, 111122

Distribution pattern: Worldwide distribution: USA Nationwide including Puerto Rico; UAE, TAIWAN, SWEDEN, THAILAND, KOREA, SINGAPORE, HONG KONG CHINA, CHILE, CANADA, AUSTRALIA, JAPAN, ENGLAND, GERMANY, and EGYPT.