CLASS II Device recall · Reported 10 Aug 2016 · FDA Enforcement Report
Zimmer¿ Air Dermatome II Handpiece w/o Hose recalled by Zimmer Surgical
Zimmer Surgical is recalling Zimmer¿ Air Dermatome II Handpiece w/o Hose, 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-2335-2016
- 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 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 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
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 # 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
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 74636This product is part of a recall event; the main page for the event is Zimmer¿ Air Dermatome II Width Plate Part # recalled by Zimmer Surgical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Zimmer¿ Air Dermatome II Width Plate Part # recalled by Zimmer Surgical | Zimmer Surgical | Packaging Defects | Nationwide | |
| CLASS II | Zimmer¿ Air Dermatome II Width Plate Part #00 recalled | Zimmer Surgical | Packaging Defects | Nationwide | |
| CLASS II | Zimmer¿ Air Dermatome II Width Plate Part #00 recalled | Zimmer Surgical | Packaging Defects | Nationwide | |
| CLASS II | Zimmer¿ Air Dermatome II Handpiece recalled by Zimmer Surgical | Zimmer Surgical | Packaging Defects | Nationwide | |
| CLASS II | Zimmer¿ Air Dermatome II Width Plate Part #00 recalled | Zimmer Surgical | Packaging Defects | Nationwide | |
| CLASS II | Zimmer¿ Air Dermatome II Width Plate recalled by Zimmer Surgical | Zimmer Surgical | Packaging Defects | Nationwide |
More recalls from Zimmer Surgical
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Sterile Tourniquet Hoses A.T.S¿ 4000 TS Tourniquet Systems recalled | Zimmer Surgical | Sterility | Nationwide |
| Device | CLASS II | Sterile Tourniquet Hoses A.T.S¿ 4000 TS Tourniquet Systems recalled | Zimmer Surgical | Sterility | Nationwide |
| Device | CLASS II | Zimmer Tourniquet Systems A.T.S.¿ 5000TS Tourniquet Systems recalled | Zimmer Surgical | Device Malfunction | OH |
| Device | CLASS II | Zimmer Tourniquet Systems A.T.S.¿ 3200TS Tourniquet Systems recalled | Zimmer Surgical | Device Malfunction | OH |
| Device | CLASS II | Zimmer Dermatome recalled by Zimmer Surgical | Zimmer Surgical | Other | OH |
Other Hip & Knee Implants recalls
All 3,111| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intellijoint Navigation System: Workstation G2 Configured recalled | Intellijoint Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |