Recall Z-2602-2018— Zimmer Surgical Inc
Class II · Terminated
Class II FDA medical device recall by Zimmer Surgical Inc, initiated 2018-06-08, terminated 2019-07-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Zimmer Dermatone AN, Model No. 88710100. Reason: Devices may have a loose control bar, which could compromise the ability to control the thickness of the graft. Devices could also have a loose width plate that if undetected, could result in an imperfect, yet still usable graft. Potential risks include harvesting a skin graft of a thickness much greater than intended, described as patient gouged, minor delay of surgery, and sub-optimal (but usable) graft..
- Recalling firm
- Zimmer Surgical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-08
- Terminated
- 2019-07-19
- Firm location
- Dover, OH, United States
Product description
Zimmer Dermatone AN, Model No. 88710100
Reason for recall
Devices may have a loose control bar, which could compromise the ability to control the thickness of the graft. Devices could also have a loose width plate that if undetected, could result in an imperfect, yet still usable graft. Potential risks include harvesting a skin graft of a thickness much greater than intended, described as patient gouged, minor delay of surgery, and sub-optimal (but usable) graft.
Data sourced from openFDA. This site is unofficial and independent of the FDA.