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

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.

Affected Products

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

Lot Numbers:

61987607

61989397

62007988

62008620

62244213

62267555

62289845

62309684

62374706

62393940

62415890

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

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

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

Lot Numbers:

61999884

62267513

62635782

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

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