FDA · Medical device recall

The Zimmer Air Dermatome… and 2 more products

June 12, 2013 Class II

Date: June 12, 2013
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Terminated
Filed by: Zimmer Surgical Inc
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.
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.

3 products in this recall

The Zimmer Air Dermatome…

Product: The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities
Quantity: 84 units
Codes and lots: 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
Recall started: May 7, 2013
Device type: Dermatome
Root cause (FDA): Process control
What the company told customers: The firm, Zimmer, sent an "URGENT: DEVICE REMOVAL" notice dated May 7, 2013, to all consignees/customers via FED Ex and Distributors via E-mail. Consignees who had devices repaired received telephone calls as well as the mailed Recall Notice. The Notice identified the devices being recalled; possible adverse events and directions to immediately stop use of and remove affected product, and obtain an RGA (Return Goods Authorization) number by calling (800)348-2759 or email information to dover.repairs@zimmer.com . to return the devices for repair to:Zimmer Surgical, Attn: QA/RA Dept.- Recall, 200 West Ohio Avenue Dover, Ohio 44622 USA; and to complete and return the Response Form-Immediate Response Required via email to CorporateQualitv.PostMarket@zimmer.com. If you have further distributed affected product(s), please provide the customer's information on the Business Response Form to Zimmer. If you have any questions regarding this action, please email us at CorporateQuality. PostMarket@zimmer.com or call 1-330-364-0989.
Recall number: Z-1483-2013

Zimmer Air Dermatome II…

Product: Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities
Quantity: 126 units
Codes and lots: Serial Number 500191 , 500192,500193, 500194,500196,500197,500198,500199, 500200, 500201,500202,500203, 500204, 500205,500206, 500207,500208,500209,500210, 500211,500212, 500213,500215,500216,500217, 500219,500220, 500221,500222, 500223, 500224, 500225,500226,500227,500228,500229,500230, 500231,500232, 500233,500234,500235,500236, 500237, 500238,500239,500240,500241 , 500242, 500243,500244,500245,500246,500247,500248,500249, 500250, 500251,500252,500253,500254, 500255,500256,500257,500258,500259, 500260,500261,500262,500263,500264, 500265,500266,500267,500268,500269, 500270,500291, 500292,500293,500295,500296,500297,500298, 500299,500300,500301 , 500302,500303, 500304, 500306, 500307,500308,500309,500310, 500331 , 500332, 500334, 500335, 500336, 500337, 500338, 500339, 500340, 500341,500342, 500343, 500344, 500345, 500346, 500347, 500348,500349, 500350, 500351 , 500352, 500353, 500354,500355, 500357, 500358, 500359, 500368, 500369,500370,500371
Recall started: May 7, 2013
Device type: Dermatome
Root cause (FDA): Process control
What the company told customers: The firm, Zimmer, sent an "URGENT: DEVICE REMOVAL" notice dated May 7, 2013, to all consignees/customers via FED Ex and Distributors via E-mail. Consignees who had devices repaired received telephone calls as well as the mailed Recall Notice. The Notice identified the devices being recalled; possible adverse events and directions to immediately stop use of and remove affected product, and obtain an RGA (Return Goods Authorization) number by calling (800)348-2759 or email information to dover.repairs@zimmer.com . to return the devices for repair to:Zimmer Surgical, Attn: QA/RA Dept.- Recall, 200 West Ohio Avenue Dover, Ohio 44622 USA; and to complete and return the Response Form-Immediate Response Required via email to CorporateQualitv.PostMarket@zimmer.com. If you have further distributed affected product(s), please provide the customer's information on the Business Response Form to Zimmer. If you have any questions regarding this action, please email us at CorporateQuality. PostMarket@zimmer.com or call 1-330-364-0989.
Recall number: Z-1484-2013

Zimmer Air Dermatome II…

Product: Zimmer Air Dermatome II, REF 00-8851-001-01 handpiece, w/o hose, Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities.
Quantity: 13 units
Codes and lots: Serial Number 500311, 500312, 500317, 500320, 500321, 500322, 500323, 500324, 500325, 500326, 500327, 500328, 500329
Recall started: May 7, 2013
Device type: Dermatome
Root cause (FDA): Process control
What the company told customers: The firm, Zimmer, sent an "URGENT: DEVICE REMOVAL" notice dated May 7, 2013, to all consignees/customers via FED Ex and Distributors via E-mail. Consignees who had devices repaired received telephone calls as well as the mailed Recall Notice. The Notice identified the devices being recalled; possible adverse events and directions to immediately stop use of and remove affected product, and obtain an RGA (Return Goods Authorization) number by calling (800)348-2759 or email information to dover.repairs@zimmer.com . to return the devices for repair to:Zimmer Surgical, Attn: QA/RA Dept.- Recall, 200 West Ohio Avenue Dover, Ohio 44622 USA; and to complete and return the Response Form-Immediate Response Required via email to CorporateQualitv.PostMarket@zimmer.com. If you have further distributed affected product(s), please provide the customer's information on the Business Response Form to Zimmer. If you have any questions regarding this action, please email us at CorporateQuality. PostMarket@zimmer.com or call 1-330-364-0989.
Recall number: Z-1485-2013

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-1483-2013, Z-1484-2013, Z-1485-2013. The agency record governs; check it and the company before acting.

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