Recall Z-1483-2019— Zimmer GmbH
Class II · Terminated
Class II FDA medical device recall by Zimmer GmbH, initiated 2019-04-08, terminated 2020-05-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Drill, cannulated, 3.5x90mm, round shaft, Item Number ST502015635. Reason: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications..
- Recalling firm
- Zimmer GmbH
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-04-08
- Terminated
- 2020-05-11
- Firm location
- Winterthur, N/A, Switzerland
Product description
Drill, cannulated, 3.5x90mm, round shaft, Item Number ST502015635
Reason for recall
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Data sourced from openFDA. This site is unofficial and independent of the FDA.