Recall Z-1483-2013— Zimmer Surgical Inc
Class II · Terminated
Class II FDA medical device recall by Zimmer Surgical Inc, initiated 2013-05-07, terminated 2014-12-15. FDA's recall record names no specific 510(k) clearance for this event. Product: The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities. Reason: This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate intermittently. Zimmer's investigation determined that the planetary gear teeth were broken. This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site..
- Recalling firm
- Zimmer Surgical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-07
- Terminated
- 2014-12-15
- Firm location
- Dover, OH, United States
Product description
The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities
Reason for recall
This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate intermittently. Zimmer's investigation determined that the planetary gear teeth were broken. This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site.
Data sourced from openFDA. This site is unofficial and independent of the FDA.