Recall Z-1431-2019— 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: Osteofresh arthrodesis drill, 2x70mm, center tip, AO, 10mm stop, Item Number 502015213. 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
Osteofresh arthrodesis drill, 2x70mm, center tip, AO, 10mm stop, Item Number 502015213
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.