Zimmer Surgical Inc: Zimmer Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. 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. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

Recall number

Z-2334-2016

Recalling firm

Zimmer Surgical Inc

Product

Zimmer Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. 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. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

Status

Terminated

Initiated

2016-07-04

Posted

2016-08-04

Terminated

2017-06-21

Reason

The surface coating applied to the device is blistering, peeling and discoloring after usage over time

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 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.

Quantity

630 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.

Lot, serial or model codes

Lot # 61977101, Serial # 500001 500019 Lot # 61980678, Serial # 500021 500040 Lot # 61989398, Serial # 500081 500090 Lot # 62008619, Serial # 500091 500110 Lot # 62083340, Serial # 500151 500170 Lot # 62096333, Serial # 500171 500190 Lot # 62122378, Serial # 500191 500210 Lot # 62191658, Serial # 500211 500230 Lot # 62191665, Serial # 500231 500250 Lot # 62220857, Serial # 500251 500270 Lot # 62220882, Serial # 500291 500310 Lot # 62244236, Serial # 500331 500350 Lot # 62266024, Serial # 500351 500371 Lot # 62267510, Serial # 500372 500391 Lot # 62267596, Serial # 500452 500471 Lot # 62289834, Serial # 500412 500431 Lot # 62309628, Serial # 500472 500491 Lot # 62309698, Serial # 500512 500531 Lot # 62369392, Serial # 500532 500551 Lot # 62374685, Serial # 500552 500571 Lot # 62374721, Serial # 500592 500611 Lot # 62393971, Serial # 500632 500651 Lot # 62394012, Serial # 500652 500671 Lot # 62454338, Serial # 500692 500711 Lot # 62476761, Serial # 500712 500731 Lot # 62494048, Serial # 500732 500751 Lot # 62494086, Serial # 500752 500771 Lot # 62525837, Serial # 500772 500791 Lot # 62554526, Serial # 500792 500811 Lot # 62578715, Serial # 500812 500831 Lot # 62578759, Serial # 500832 500851 Lot # 62635778, Serial # 500852 500871

510(k) numbers

not on file

PMA numbers

not on file

Product code

GFD

Firm FEI

1526350

Firm city

Dover

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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