Recall Z-2226-2014— Zimmer, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer, Inc., initiated 2014-07-23, terminated 2015-09-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Double Offset Rasp Handle, Left Hand A/S Rasp Handle (Left). Reason: The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring..
- Recalling firm
- Zimmer, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-07-23
- Terminated
- 2015-09-15
- Firm location
- Warsaw, IN, United States
Product description
Double Offset Rasp Handle, Left Hand A/S Rasp Handle (Left)
Reason for recall
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
Data sourced from openFDA. This site is unofficial and independent of the FDA.