Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 16, 2016
Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device 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.
Zimmer Biomet Surgical has received product complaints reporting that the surface coating applied to the device is blistering, peeling and discoloring after usage over time (see I…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Zimmer Surgical Inc recalled Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged… - a moderate-severity action.
Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged… was recalled by Zimmer Surgical Inc in November 16, 2016. Reason: Zimmer Biomet Surgical has received product complaints reporting that the surface coating applied to the devi…. Check the official notice for the remedy. Verify recall #Z-0368-2017 with the FDA Devices before acting.
The recall
Zimmer Surgical Inc issued this moderate-severity FDA Devices recall-Zimmer Biomet Surgical has received product complaints reporting that the surface coating applied to the devi….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- November 16, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0368-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0368-2017) was formally reported on November 16, 2016, with the manufacturer initiating the action on July 4, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Zimmer Surgical Inc is listed as the recalling firm, operating out of Dover, OH. Federal records list the affected scope as 1030 units.
The documented reason for this recall is: Zimmer Biomet Surgical has received product complaints reporting that the surface coating applied to the device is blistering, peeling and discoloring after usage over time (see Image 1). There have been no injuries ass… Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1030 units
Related Recalls
6
3 from same agency
Product description
Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device 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.
Reason for recall
Zimmer Biomet Surgical has received product complaints reporting that the surface coating applied to the device is blistering, peeling and discoloring after usage over time (see Image 1). There have been no injuries associated with the reported complaints. In addition, an independent assessment determined that the blistering, peeling and potentially flaking of the surface coating is not expected to result in any long range health consequences. Given that the frequency of this surface coating condition can worsen with age, Zimmer Biomet Surgical is currently making preparations for replacement activities to follow in order to prevent future complaints. This document is provided to alert all users of the potential for the surface coating to exhibit blistering, peeling, and discoloring after usage over time. A separate recall removal notice will be issued to facilities, in phases, with detailed instructions beginning in August 2016. Your sales representatives will be notified when a replacement is ready. Do not return product at this time as part of this action. Image 1.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0368-2017 |
| Date reported | November 16, 2016 |
| Date initiated | July 4, 2016 |
| Recalling firm | Zimmer Surgical Inc |
| Firm location | Dover, OH |
| Affected scope | 1030 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0368-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device 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.. Recalled by Zimmer Surgical Inc. Units affected: 1030 units.
Why was this product recalled? ▼
Zimmer Biomet Surgical has received product complaints reporting that the surface coating applied to the device is blistering, peeling and discoloring after usage over time (see Image 1). There have been no injuries associated with the reported complaints. In addition, an independent assessment determined that the blistering, peeling and potentially flaking of the surface coating is not expected to result in any long range health consequences. Given that the frequency of this surface coating condition can worsen with age, Zimmer Biomet Surgical is currently making preparations for replacement activities to follow in order to prevent future complaints. This document is provided to alert all users of the potential for the surface coating to exhibit blistering, peeling, and discoloring after usage over time. A separate recall removal notice will be issued to facilities, in phases, with detailed instructions beginning in August 2016. Your sales representatives will be notified when a replacement is ready. Do not return product at this time as part of this action. Image 1.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 16, 2016. Severity: Moderate. Recall number: Z-0368-2017.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0368-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 16, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.