Z-2340-2016Class II

Zimmer Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. Width plate is packaged inside of a...

Name: Z-2340-2016 Zimmer Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. Width plate is packaged inside of a...
Creator: Zimmer Surgical Inc
Published: 2016-07-04
License: https://open.fda.gov/license/

Zimmer Surgical SA / initiated 2016-07-04 / Terminated / root cause: manufacturing process

FDA source

Zimmer Surgical Inc began a recall of 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... on 2016-07-04. FDA classified it as Class II and gives the reason as "The surface coating applied to the device is blistering, peeling and discoloring after usage over time". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2340-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-04
Posted: 2016-08-04
Terminated: 2017-06-21
Recalling firm: Zimmer Surgical SA
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.
Product code: GFD Dermatome
Reason for recall: The surface coating applied to the device is blistering, peeling and discoloring after usage over time
Root cause tag: manufacturing process
FDA 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 [email protected]. 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 [email protected]. 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 in commerce: 110 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2340-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2334-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-04
Z-2335-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-04
Z-2336-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-04
Z-2337-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-04
Z-2338-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-04
Z-2339-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-04
Z-2340-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-04

Product code GFD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)