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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

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

Agency Publication Date: August 4, 2016
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Affected Products

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

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

Lot Numbers:
61977101
61980678
61989398
62008619
62083340
62096333
62122378
62191658
62191665
62220857
62220882
62244236
62266024
62267510
62267596
62289834
62309628
62309698
62369392
62374685
62374721
62393971
62394012
62454338
62476761
62494048
62494086
62525837
62554526
62578715
62578759
62635778
Product: Zimmer¿ Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. 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 De

Lot # 61987607, Serial # 500041  500060 Lot # 61989397, Serial # 500061  500080 Lot # 62007988, Serial # 500111  500130 Lot # 62008620, Serial # 500131  500150 Lot # 62244213, Serial # 500311  500330 Lot # 62267555, Serial # 500392  500411 Lot # 62289845, Serial # 500432  500451 Lot # 62309684, Serial # 500492  500511 Lot # 62374706, Serial # 500572  500591 Lot # 62393940, Serial # 500612  500631 Lot # 62415890, Serial # 500672  500691

Lot Numbers:
61987607
61989397
62007988
62008620
62244213
62267555
62289845
62309684
62374706
62393940
62415890
Product: Zimmer¿ Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 . Width plates 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. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

Lot # 61999883, Serial # N/A Lot # 62243337, Serial # N/A Lot # 62282028, Serial # N/A Lot # 62393990, Serial # N/A

Lot Numbers:
61999883
62243337
62282028
62393990
Product: Zimmer¿ Air Dermatome II Width Plate, 2 inch. Part # 885120200. Width plate 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. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

Lot # 61999885, Serial # N/A Lot # 62267472, Serial # N/A Lot # 62339198, Serial # N/A Lot # 62629006, Serial # N/A

Lot Numbers:
61999885
62267472
62339198
62629006
Product: Zimmer¿ Air Dermatome II Width Plate, 1.5 inch. Part #00-8851-215-00. Width plate 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. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

Lot # 61999884, Serial # N/A Lot # 62267513, Serial # N/A Lot # 62635782, Serial # N/A

Lot Numbers:
61999884
62267513
62635782
Product: Zimmer¿ Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. Width plate 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. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

Lot # 61999886, Serial # N/A Lot # 62267473, Serial # N/A Lot # 62339165, Serial # N/A Lot # 62606085, Serial # N/A

Lot Numbers:
61999886
62267473
62339165
62606085
Product: Zimmer¿ Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. Width plate 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. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

Lot # 61999890, Serial # N/A Lot # 62267474, Serial # N/A Lot # 62339193, Serial # N/A Lot # 62561320, Serial # N/A Lot # 62662647, Serial # N/A

Lot Numbers:
61999890
62267474
62339193
62561320
62662647

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 74636
Status: Resolved
Manufacturer: Zimmer Surgical Inc
Manufactured In: United States
Units Affected: 7 products (630 units; 220 units; 70 units; 90 units; 60 units; 90 units; 110 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.