CLASS II Device recall · Reported 10 Aug 2016 · FDA Enforcement Report
Zimmer¿ Air Dermatome II Width Plate Part #00 recalled
Zimmer Surgical is recalling Zimmer¿ Air Dermatome II Width Plate Part #00-8851-215-00, distributed nationwide in the US. The recall was initiated on 4 Jul 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2338-2016
- FDA event ID
- 74636
- Recalling firm
- Zimmer Surgical, Dover, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Jul 2016
- FDA classified
- 4 Aug 2016
- Reported
- 10 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 4 Jul 2016 | Recall initiated by company | |
| 4 Aug 2016 | Classified by FDA | +31 days |
| 10 Aug 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The surface coating applied to the device is blistering, peeling and discoloring after usage over time
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesota
Questions about this recall
Is Zimmer¿ Air Dermatome II Width Plate Part #00-8851-215-00 recalled?
Yes. Zimmer Surgical recalled Zimmer¿ Air Dermatome II Width Plate Part #00-8851-215-00 on 4 Jul 2016. The recall is Class II and its status is Terminated. Recall number Z-2338-2016.
Why was it recalled?
The surface coating applied to the device is blistering, peeling and discoloring after usage over time
Which lots are affected?
Lot # 61999884, Serial # N/A Lot # 62267513, Serial # N/A Lot # 62635782, Serial # N/A
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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